Methods

RCT, parallel‐arm

Children randomly assigned

Conducted in the dental clinic of Azad University, Tehran, Iran. Operators were a dentist under the supervision of an endodontist

Participants

126 children, 126 teeth, mean age 6.5 years, standard deviation age 1.16 years, age range 5 to 9 years

Interventions

Group 1: Pulpotomy (formocresol); n = 75 (1 visit)

Rubber dam

Caries removal prior to pulpal access: not mentioned

Pulp access with high‐speed burr

Pulpotomy amputation with excavator

For haemostasis, moistened cotton pellet with saline

Irrigation with saline
Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by zonalin dressings before being restored with amalgam or glass‐ionomer cement

Group 2: Pulpotomy (MTA); n = 51 (1 visit)

Rubber dam

Caries removal prior to pulpal access: not mentioned

Pulp access with high‐speed burr

Pulpotomy amputation with excavator

For haemostasis, moistened cotton pellet with saline

Irrigation with saline MTA applied after pulpotomy, followed by amalgam

Outcomes

Clinical failure (spontaneous pain, swelling, pain on palpation or percussion and sinus tract formation, periodontal ligament widening, furcal radiolucency or apical radiolucency), pathological root resorption: evaluation at 3 and 6 months (at tooth level)

Radiological failure (pathological root resorption, periodontal ligament widening and apical, lateral or furcal radiolucency): evaluation at 3 months (at tooth level)

Notes

Reasons for dropouts: quote: "18 in the FC group and 8 in the MTA group did not attend the 3‐month follow‐up"

Comment: 55 participants excluded: not meeting inclusion (39 children), refused to participate (12 children), other reasons (4 children)

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number producing system

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, split‐mouth

Teeth randomly assigned

Conducted in the Paediatric Dentistry Department, Alexandria University, Alexandria, Egypt. Operators not mentioned

Participants

24 children, 72 teeth, mean age 6.1 years, age range 4‐8 years

Interventions

Group 1: Pulpotomy (grey MTA); n = 24 (1 visit)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access with high‐speed bur

Pulpotomy amputation with excavator

For haemostasis, moistened cotton pellet with water

No irrigation

Grey MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crowns

Group 2: Pulpotomy (white MTA); n = 24 (1 visit)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access with high‐speed bur

Pulpotomy amputation with excavator

For haemostasis, moistened cotton pellet with water

No irrigation

White MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crowns

Group 3: Pulpotomy (formocresol); n = 24 (1 visit)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access with high‐speed bur

Pulpotomy amputation with excavator

For haemostasis, moistened cotton pellet with water

No irrigation

Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM dressings before being restored with stainless‐steel crowns

Outcomes

Clinical success (no pain symptoms, or no tenderness to percussion, or no swelling, or no fistulation, or no pathological mobility), radiographic success (no radicular radiolucency, or internal or external resorption, or periodontal ligament space widening), radicular radiolucency, pulp canal obliteration: evaluation at 1, 3, 6 and 12 months (at tooth level)

Notes

Reasons of dropouts: quote: "Four children with 12 pulpotimized molars, failed to return for evaluations and were excluded from the study"

Comment: 17% of participants (8% of teeth) dropped out of the study. The reasons for failure to return were not reported

Source of funding: quote "This study was supported by the Zawawi Pediatric Dentistry Fund of the Indiana University Foundation. [...] The authors also wish to thank Dentsply Tulsa Dental for donating the MTA materials used in this study"

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "Two examiners, who were blinded to the treatment type, evaluated the teeth clinically"

Blinding of radiological outcomes assessment

Low risk

Quote: "Two examiners, who were blinded to the treatment type, evaluated the teeth [...] and radiographically"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, split‐mouth

Teeth randomly assigned

Conducted in the Pediatric Dentistry Department, Faculty of Dentistry, Ankara University. Operators not mentioned

Participants

64 children, 128 teeth, mean age 8.2 years, age range 6‐10 years

Interventions

Group 1: Pulpotomy (CH NaCOl); n = 31 (1 visit)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access not mentioned

Pulpotomy amputation with excavator

For haemostasis, dry cotton pellet

Irrigation with 5% NaOCl for 30 seconds, then water

CH, followed by IRM then stainless steel crown

Group 2: Pulpotomy (CH); n = 31 (1 visit)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access not mentioned

Pulpotomy amputation with excavator

For haemostasis, dry cotton pellet

Irrigation with saline for 30 seconds then water

CH, followed by IRM then stainless steel crown

Group 3: Pulpotomy (MTA NaOCl); n = 31 (2 visits)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access not mentioned

Pulpotomy amputation with excavator

For haemostasis, dry cotton pellet

Irrigation with 5% NaOCl for 30 seconds then water

MTA, followed by a moistened cotton pellet, followed by IRM. Second visit: IRM and the cotton pellets were removed after 24 hours, then stainless steel crown

Group 4: Pulpotomy (MTA); n = 31 (2 visits)

Rubber dam

Caries removal prior to pulpal access not mentioned

Pulp access not mentioned

Pulpotomy amputation with excavator

For haemostasis, dry cotton pellet

Irrigation with saline for 30 seconds then water

MTA, followed by a moistened cotton pellet, followed by IRM. Second visit: IRM and the cotton pellets were removed after 24 hours, then stainless steel crown

Outcomes

clinical success (absence of spontaneous pain, pathologic mobility, tenderness to percussion, swelling, fistula, or gingival inflammation), radiographic success (absence of internal/external root resorption and periapical/furcal radiolucency), calcific metamorphosis of the pulp: evaluation at 3, 6, 9 and 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

a toss of a coin

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

quote: "One examiner, who was blinded to treatment type, evaluated the teeth clinically "

Blinding of radiological outcomes assessment

Low risk

quote: "One examiner, who was blinded to treatment type, evaluated the teeth [...] radiographically"

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

missing data balanced in numbers across intervention groups, with similar reasons for missing data across groups (2 in each group because of uncontrolled bleeding)

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Department of Pedodontics and Preventive Dentistry at School of Dentistry, Damascus, Syria. Operators not mentioned

Participants

39 children, 64 teeth, mean age 8.2 years, age range 3 to 9 years

Interventions

Group 1: Pulpectomy (zinc oxide and propolis); n = 16 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed

• Pulpotomy amputation with excavator

• Irrigation with 5.25% sodium hypochlorite then distilled water the working length was determined by electronic apex locator, the root canals were prepared manually using K file up to size no. 30 root canals were dried with paper point (size 25)

• The hydrolytic propolis of ZOP paste was extracted from raw Propolis. ZOP paste was synthesised by mixing 50% zinc oxide powder with 50% hydrolytic propolis, to form radiopaque paste with appropriate viscosity for filling the root canal. Paste was inserted into the root canal using Lentulo spirals at low speed. a thin layer of the filling paste was put on the floor of pulp chamber, followed by glass‐ionomer cement then stainless steel crown

Group 2: Pulpectomy (endoflas‐chlorophenol‐free); n = 16 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed

• Pulpotomy amputation with excavator

• Irrigation with 5.25% sodium hypochlorite then distilled water

• the working length was determined by electronic apex locator, the root canals were prepared manually using K file up to size no. 30

• root canals were dried with paper point (size 25)

• The powder of Endoflas‐CF paste was synthesized by adding 56.5% zinc oxide, 40.6% iodoform, 1.63% barium sulphate and 1.07% calcium hydroxide, and mixed with eugenol without adding chlorophenol. Paste was inserted into the root canal using Lentulo spirals at low speed.

• A thin layer of the filling paste was put on the floor of pulp chamber, followed by glass‐ionomer cement then stainless steel crown

Group 3: Pulpectomy (Metapex); n = 16 (2 visits)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed

• Pulpotomy amputation with excavator

• Irrigation with 5.25% sodium hypochlorite then distilled water

• The working length was determined by electronic apex locator, the root canals were prepared manually using K file up to size no. 30

• Root canals were dried with paper point (size 25)

• Performed syringe with disposable plastic needles to inject the paste into the root canal; after inserting the tape of the needle near the apex, and the paste was gently pressed into the canal pulling the tape back slowly until the canal was filled.

• A thin layer of the filling paste was put on the floor of pulp chamber, followed by glass‐ionomer cement then stainless steel crown

Group 4: Pulpectomy (ZOE); n = 16 (2 visits)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed

• Pulpotomy amputation with excavator

• Irrigation with 5.25% sodium hypochlorite then distilled water

• the working length was determined by electronic apex locator, the root canals were prepared manually using K file up to size no. 30

• root canals were dried with paper point (size 25)

• Paste was inserted into the root canal using Lentulo spirals at low speed.

• a thin layer of the filling paste was put on the floor of pulp chamber, followed by glass‐ionomer cement then stainless steel crown

Outcomes

Clinical success (no abnormal mobility, pain, or sensitivity to percussion), radiographic success (decrease in the size of radiolucency and the presence of bone regeneration), at 6 and 12 months. Treatment failure was classified into two degrees as (a) the radiolucency slightly increased in size, but it was separated from succeeding bud with adequate bone and (b) the radiolucency threatening the succeeding buds, so the tooth was extracted.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "The treated molars were evaluated double‐blindly by three observers"

Blinding of radiological outcomes assessment

Low risk

Quote: "The treated molars were evaluated double‐blindly by three observers"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in Turkey. Setting and operators not mentioned

Participants

42 children, 69 teeth, age range 7 to 11 years

Interventions

Group 1: Pulpotomy (glutaraldehyde + ZOE); n = 25 (1 visit)

• No rubber dam: cotton rolls

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• For haemostasis, dry cotton pellet

• Irrigation with 3% hydrogen peroxide and sterile saline

• Cotton wool pellet soaked with 2% unbuffered glutaraldehyde placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE. Final restoration not mentioned

Group 2: Pulpotomy (glutaraldehyde + calcium hydroxide); n = 21 (1 visit)

• No rubber dam: cotton rolls

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• For haemostasis, dry cotton pellet

• Irrigation with 3% hydrogen peroxide and sterile saline

• Cotton wool pellet soaked with 2% unbuffered glutaraldehyde placed on pulp stumps for 5 minutes after pulpotomy, followed by CH. Final restoration not mentioned

Group 3: Pulpotomy (formocresol + ZOE); n = 23 (1 visit)

• No rubber dam: cotton rolls

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• For haemostasis, dry cotton pellet

• Irrigation with 3% hydrogen peroxide and sterile saline

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE.

• Final restoration not mentioned

Outcomes

Clinical success (pain symptoms, thermal sensitivity, tenderness to percussion, changes in the mucous membrane in the surrounding area, sensitivity to sour, sensitivity to sweet), radiological success (internal root resorption, changes in the integrity of lamina dura, abnormalities in the structure of trabecular bone): evaluation at 3 months (at tooth level)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Children randomly assigned

Conducted in the University of Gazi Department of Pediatric Dentistry, Turkey. Operators were undergraduate dental students supervised by members of senior staff clinics

Participants

105 children, 105 teeth, mean age 6.4 years, age range 4 to 8 years

Interventions

Group 1: Pulpotomy (formocresol); n = 35 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet with saline

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 3 minutes after pulpotomy, followed by 1 non‐specified medicament dressings before being restored with stainless‐steel crowns

Group 2: Pulpotomy (calcium hydroxide); n = 35 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet with saline

• No irrigation

• CH applied after pulpotomy, followed by one non‐specified medicament dressings before being restored with stainless‐steel crowns

Group 3: Pulpotomy (calcium hydroxide/iodoform)n = 35 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet with saline

• No irrigation

• CH/iodoform applied after pulpotomy, followed by 1 non‐specified medicament dressings before being restored with stainless‐steel crowns

Outcomes

Clinical success (teeth remained asymptomatic, no tenderness to percussion, no sinus tract or no premature tooth loss), radiological success (no furcal or periapical radiolucencies or internal or external root resorption), tenderness to percussion, swelling, spontaneous pain, fistula, internal root resorption, external root resorption, periapical radiolucency, furcal radiolucency, widened periodontal ligament: evaluation at 1, 3, 6, 9 and 12 months (at tooth level)

Notes

Quote: "9 children, with 9 pulpotomized molars, failed to return for evaluations and were excluded from the study"

"5 bleeding cases were excluded from analysis"

Group 1 ‐ received intervention, n = 35; no exclusions

Group 2 ‐ received intervention, n = 33; excluded due to uncontrolled bleeding from paste placement n = 2

Group 3 ‐ received intervention, n = 32; excluded due to uncontrolled bleeding from paste placement n = 3

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Low risk

Quote: "Radiographic outcome assessments were made by the primary investigator and 1 independent experienced clinician who was blind to the treatment"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Proportion of missing outcomes < 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Department of Pediatric Dentistry, Tabriz University of Medical Science, Iran. Operator was an expert paediatric dentist.

Participants

83 children, 160 teeth, mean age 5.14 years, age range 3 to 6 years

Interventions

Group 1: direct pulp capping (3 Mix); n = 40 (1 visit)

• Rubber dam

• Chlorhexidine

• Caries removal prior to pulpal access

• Pulp access with slow‐speed bur

• Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

• For haemostasis, moistened cotton pellet

• 3Mix mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5 to 2 mm and extending 2 mm beyond the margins of the exposure site

• dry cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.

Group 2: direct pulp capping (3 Mixtatin); n = 40 (1 visit)

• Rubber dam

• Chlorhexidine

• Caries removal prior to pulpal access

• Pulp access with slow‐speed bur

• Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

• For haemostasis, moistened cotton pellet

• 3Mixtatin mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5–2 mm and extending 2 mm beyond the margins of the exposure site

• dry cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.

Group 3: direct pulp capping (simvastatin); n = 40 (1 visit)

• Rubber dam

• chlorhexidine

• Caries removal prior to pulpal access

• Pulp access with slow‐speed bur

• Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

• For haemostasis, moistened cotton pellet

• Simvastatin mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5–2 mm and extending 2 mm beyond the margins of the exposure site

• dry cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.

Group 4: direct pulp capping (White MTA); n = 40 (1 visit)

• Rubber dam

• chlorhexidine

• Caries removal prior to pulpal access

• Pulp access with slow‐speed bur

• Irrigation with water and 1% of NaOCl delivered by a syringe and needle every 3 min to wash away dentin debris and remove the blood clot, if present

• For haemostasis, moistened cotton pellet

• MTA mixed with normal saline to form a creamy mixture and were delivered to the exposure site using a small amalgam carrier to reach a thickness of 1.5–2 mm and extending 2 mm beyond the margins of the exposure site

• wet cotton pellet was pressed slightly for better adaptation of capping material with pulp at the exposure site. After removing the cotton pellet, the capping material was covered by IRM then glass ionomer before being restored by amalgam.

Outcomes

Failure of treatment: pain, tenderness to palpation and percussion, sinus tract, and swelling; presence of internal or external root resorption, inter‐radicular radiolucency, and periapical lesion: evaluation at 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Using a computer random number generator

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "The operator was not blinded to the treatment because of different manipulation techniques implemented for the study groups"

Blinding of clinical outcomes assessment

Low risk

Quote: "clinical and radiographic examinations were conducted at each appointment by two experienced paediatric dentists that were blinded to the techniques applied to each group"

Blinding of radiological outcomes assessment

Low risk

Quote: "clinical and radiographic examinations were conducted at each appointment by two experienced paediatric dentists that were blinded to the techniques applied to each group"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Department of Pediatric Dentistry at Tabriz University of Medical Sciences School of Dentistry, Iran. Operators not mentioned

Participants

84 children, 120 teeth, mean age 4.4 years, age range 4 to 5 years

Interventions

Group 1: Direct pulp capping (formocresol + ZOE); n = 60 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with slow‐speed bur

• No pulpotomy amputation

• Haemostasis not mentioned

• Irrigation with saline

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes for direct pulp capping, followed by ZOE dressings before being restored with stainless‐steel crowns

Group 2: Direct pulp capping (calcium hydroxide + ZOE); n = 60 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with slow‐speed bur

• No pulpotomy amputation

• Haemostasis not mentioned

• Irrigation with saline

• CH applied for direct pulp capping, followed by ZOE dressings before being restored with stainless‐steel crowns

Outcomes

Clinical success (spontaneous pain, or pain initiated by stimuli; signs of a defective restoration or recurrent caries; signs of mobility, sinus formation, tenderness to percussion, or soft tissue swelling; and signs of exfoliation, mobility or signs/symptoms of the successor tooth erupting), radiological success (defective restoration or recurrent caries; periradicular pathology such as periapical or furcal radiolucency; and pathological internal resorption, replacement resorption, intracanal calcifications, or physiological root resorption): evaluation at 24 months (at tooth level)

Spontaneous pain, tenderness to percussion, fistula or parulis, periapical radiolucency or furcal radiolucency, internal resorption or external resorption: evaluation at 6, 12, 18 and 24 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Coin toss

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "objectivity was maximized by not having direct access during [...] clinical evaluation to records detailing which pulp therapy agent was used"

Blinding of radiological outcomes assessment

Low risk

Quote: "objectivity was maximized by not having direct access during [...] radiological evaluation to records detailing which pulp therapy agent was used"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, split‐mouth

Teeth randomly assigned

Conducted in the Paedodontic Department at Shahid Beheshti University, Dental School, Iran. Operator was an investigator

Participants

17 children, 40 teeth, age range 4 to 9 years

Interventions

Group 1: Pulpotomy (formocresol); n = 20 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access not mentioned

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet with saline

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM dressings before being restored with amalgam or stainless‐steel crowns

Group 2: Pulpotomy (MTA); n = 20 (2 visits)

• Rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access not mentioned

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet with saline

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM dressings before being restored with amalgam or stainless‐steel crowns

• MTA applied after pulpotomy, then temporarily filled using an IRM, until the second visit for placement of ZOE base. dressings before being restored with stainless‐steel crowns

Outcomes

Signs of failure (internal resorption, radiographic signs of pathosis (periapical radiolucency), report of pain, presence of gingival swelling and sinus tract): evaluation at 24 months (at tooth level)

Fistula, furcal radiolucency, periapical radiolucency, internal resorption, external resorption, periodontal ligament widening, pulp canal obliteration: evaluation at 6, 12 and 24 months (at tooth level)

Notes

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in Turkey. Operator was a paediatric dentist

Participants

50 children, 50 teeth, age range 4 to 9 years

Interventions

Group 1: Pulpectomy (IRM); n = 25 (3 visits)

• isolation with no precision

• Caries removal prior to pulpal access

• Pulp access with no precision

• Pulpotomy amputation with no precision

• Irrigation with 2.5% sodium hypochlorite and physiological saline

• Instrumentation with H‐files

• canals were dried with paper points and Cresophene was applied in the pulp chamber with a cotton pellet and tooth was filled with Cavit. After 48 hours, canals were irrigated with NaOCl and physiologic saline, dried with paper points, and filled with a Ca(OH)2/iodoform paste using plastic syringe provided by the manufacturer and Lentulo spirals. Following root canal fillings, base materials were applied to the cavity floor and cavities were temporarily filled with IRM. IRM was removed from the cavity until approximately 3mm of the material is left on the pulpal floor and the cavity was filled with metal‐reinforced glass ionomer cement, before being restored with stainless steel crowns

Group 2: Pulpectomy (MTA); n = 25 (3 visits)

• isolation with no precision

• Caries removal prior to pulpal access

• Pulp access with no precision

• Pulpotomy amputation with no precision

• Irrigation with 2.5% sodium hypochlorite and physiological saline

• Instrumentation with H‐files

• canals were dried with paper points and Cresophene was applied in the pulp chamber with a cotton pellet and tooth was filled with Cavit. After 48 hours, canals were irrigated with NaOCl and physiologic saline, dried with paper points, and filled with a Ca(OH)2/iodoform paste using plastic syringe provided by the manufacturer and Lentulo spirals. Following root canal fillings, base materials were applied to the cavity floor and cavities were temporarily filled with IRM. after approximately 3mm of MTA was placed on the pulpal floor a moistened cotton pellet in contact to MTA was left in the cavity before the application of the temporary filling material. After 24 hours, temporary filling and moistened cotton pellet were removed and the cavity was filled with metal‐reinforced glass ionomer cement, before being restored with stainless steel crowns

Outcomes

Clinical failure (pain, pathological mobility, tenderness to percussion and palpation, and any soft tissue pathology and sinus tract) and radiographical failure (pathological root resorption, reduced size or healing of existing lesion, and absence of new lesions at the interradicular or periapical area): evaluation at 3, 6, 12 and 18 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "Examiners were blinded to the groups"

Blinding of radiological outcomes assessment

Low risk

Quote: "Examiners were blinded to the groups"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Pedodontics Department of Yazd Faculty of Dentistry, Iran. Operators were the principal investigator or co investigators

Participants

46 children, 70 teeth, mean age 6.1 years, standard deviation age 1.4 years, age range 4 to 10 years

Interventions

Group 1: Pulpotomy (formocresol); n = 35 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator, slow‐speed bur, or both

• For haemostasis, cotton pellet

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE dressings before being restored with amalgam

Group 2: Pulpotomy (electrosurgery); n = 35 (2 visits)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator, slow‐speed bur, or both

• For haemostasis, cotton pellet

• No irrigation

In the experimental electrosurgical group, a series of large, sterile cotton pellets were placed in the chamber with pressure to obtain temporary haemostasis. The cotton pellets were then removed and the electrosurgery dental U‐shaped electrode (Whaledent perfect TCS, Colten Whaledent Inc., USA) was immediately placed 1 to 2 mm above the tissue. The electrosurgery unit power was set at 40%. The electrical arc was allowed to bridge the gap to the first pulpal stump for 1 second followed by a cool‐down period of 10 to 15 seconds. Heat was minimised by keeping the electrode as far away from the pulpal stumps and the tooth structure as possible while still allowing electrical arcing to occur. This procedure was repeated up to 3 times at each pulpal orifice. To avoid heat build‐up in any 1 area of the tooth, single applications of 1 second were performed to each orifice in a rotational sequence. After each current application, a new large sterile cotton pellet was placed with pressure on the next pulpal orifice to be electrosurgically treated to absorb any blood or tissue fluid before the next current application (i.e. pellet‐electrode‐pellet‐electrode). Pulpal stumps were dry and blackened, followed by ZOE dressings before being restored with amalgam

Outcomes

Clinical success (absence of pain, abscess, fistula or excessive mobility), radiological success (presence of a normal periodontal ligament space, absence of pathological root resorption or canal calcification, and no periradicular or furcal radiolucency): evaluation at 9 months (at tooth level)

Pain symptoms, fistula, pathological mobility, abscess, furcal radiolucency, internal resorption, external resorption: evaluation at 3, 6 and 9 months

Notes

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "...examiner who was ...blind to the treatment"

Blinding of radiological outcomes assessment

Low risk

Quote: "...examiner who was ...blind to the treatment"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in Turkey. Operator was a paediatric dentist

Participants

16 children, 20 teeth, age range 6 to 13 years, mean age 10.5 years

Interventions

Group 1: Pulpectomy (gutta‐percha/AH‐Plus); n = 10 (1 visit)

• rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access with no precision

• Pulpotomy amputation with no precision

• Irrigation with 1% sodium hypochlorite and physiological saline

• Instrumentation with K‐files and barbed broaches

• Canals were completely filled with gutta‐percha points using a Size 30 master cone and Size 25, 20 and 15 accessory cones applied with finger spreaders sizes 25 and 20 and AH‐Plus Sealer using a cold lateral condensation technique. Final restorations were completed in the same session using reinforced glass ionomer cement and composite resin.

Group 2: Pulpectomy (MTA); n = 10 (2 visits)

• rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access with no precision

• Pulpotomy amputation with no precision

• Irrigation with 1% sodium hypochlorite and physiological saline

• Instrumentation with K‐files and barbed broaches

• White MTA was mixed according to the manufacturer’s recommendations, placed in the canal using the MTA Gun System and compacted using endodontic pluggers. The MTA was allowed to set completely by placing a cotton pellet moistened with sterile water inside the pulp chamber and temporarily sealing the access cavity with reinforced glass ionomer cement. After 2 days, the temporary restoration was removed, and the cavities were permanently restored using reinforced glass ionomer cement and composite resin as a final restoration.

Outcomes

Clinical success (no symptoms of pain, tenderness to percussion, swelling, and presence of a fistula or pathological mobility), radiographic success (no evidence of periradicular or interradicular radiolucency or internal or external root resorption): evaluation at 6, 12, 18, 24 and 36 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

High risk

Quote: "examiners could not be blinded to the type of the root canal filling"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, split‐mouth

Teeth randomly assigned

Conducted in the clinic of the Department of Pediatric Dentistry, Erciyes University, Kayseri, Turkey. Operators were not mentioned

Participants

35 children, 70 teeth, age range 4 to 6 years

Interventions

Group 1: Pulpotomy (Ankaferd Blood Stopper); n = 35 (1 or 2 visits)

• Isolation not mentioned

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, water dampened cotton pellets

• Irrigation with saline solution applied on the pulp stumps with a dental syringe for 15 seconds, and the pulp stumps were rinsed with saline solution and pulp chamber was dried with sterile cotton pellets, followed by IRM dressings before being restored with glass ionomer cement then stainless steel crown

Group 2: Pulpotomy (FS); n = 35 (1 or 2 visits)

• Isolation not mentioned

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, water dampened cotton pellets

• Irrigation with saline solution applied on the pulp stumps with a dental syringe for 15 seconds, and the pulp stumps were rinsed with saline solution and pulp chamber was dried with sterile cotton pellets, followed by IRM dressings before being restored with glass ionomer cement then stainless steel crown

Outcomes

Clinical failure (pain, tenderness to percussion, gingival abscess, sinus/fistula, and pathological mobility), radiographic success (absence of abnormal root resorption, internal root resorption, furcation involvement, and periapical bone destruction), Calcification in pulpal tissue and pulp canal obliteration: evaluation at 3, 6, 9 and 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "All pre‐ and postoperative clinical and digital radiographic examinations were performed at followup by one experienced investigator who was blind to the group being studied"

Blinding of radiological outcomes assessment

Low risk

Quote: "All pre‐ and postoperative clinical and digital radiographic examinations were performed at followup by one experienced investigator who was blind to the group being studied"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Proportion of missing outcomes < 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Hospital for Sick Children, Toronto, Canada. Operators were 3 paediatric dentists

Participants

130 children, 291 teeth, mean age 4.4 years, standard deviation age 1.3 years

Interventions

Group 1: Pulpotomy (ferric sulphate); n = 182 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed, followed by slow‐speed bur

• Pulpotomy amputation with slow speed bur

• Haemostasis not mentioned

• No irrigation

• A 16% FS equivalent in an aqueous vehicle was gently burnished on the pulp stumps with the syringe applicator for 15 seconds after pulpotomy. Then the pulp chamber was flushed with water supplied by an air‐water syringe, followed by fortified ZOE mixture supplied in pre‐measured capsules dressings before being restored with amalgam or stainless‐steel crowns

Group 2: Pulpectomy (ZOE); n = 109 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed, followed by slow‐speed bur

• Pulpotomy amputation not mentioned

• No haemostasis

• No irrigation

• Instrumentation with files

• The canals were then irrigated and gently air dried using an air‐water syringe, then viscous mixture of Sedanol (a fine‐grained, non‐reinforced ZOE) was delivered to the root canal with a spiral paste filler inserted into the canal to a point just short of the apex, dressings before being restored with stainless‐steel crowns

Outcomes

Radiological success (N ‐ normal molar without evidence of radiographic change or H ‐ radiographic changes associated with normal physiological molar resorption): evaluation at 36 months (at tooth level)

Furcal radiolucency, periapical radiolucency, internal root resorption, external resorption, periodontal ligament widening, pulp canal obliteration, N (score 4‐rx), H (score 4‐rx), Po (score 4‐rx), Px (score 4‐rx), pain symptoms, tenderness to percussion, (swelling or parulis), (fistula or swelling): evaluation at 24 and 36 months

Notes

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the paediatric dental clinic at the School of Dentistry, Hacettepe University, Ankara, Turkey. Operator was a paediatric dentist.

Participants

75 children, 139 teeth, 3 to 9 years

Interventions

Group 1: Pulpotomy (ProRoot MTA); n = 46 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed, followed by slow‐speed bur

• Pulpotomy amputation with high speed followed by excavator

• Haemostasis with saline‐moistened sterile cotton pellets for two to four minutes

• Irrigation with saline

• White MTA mixed according to the manufacturer’s instructions to produce a homogenous paste.The material was placed in the pulp chamber with a plastic carrier. Light pressure was applied with moist cotton pellets to enhance adaptation of the material. Then followed by conventional glass ionomer cement then by amalgam (followed by fissure sealant at the margins).

Group 2: Pulpotomy (MTA Angelus); n = 45 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed, followed by slow‐speed bur

• Pulpotomy amputation with high speed followed by excavator

• Haemostasis with saline‐moistened sterile cotton pellets for two to four minutes

• Irrigation with saline

• Angelus MTA mixed according to the manufacturer’s instructions to produce a homogenous paste.The material was placed in the pulp chamber with a plastic carrier. Light pressure was applied with moist cotton pellets to enhance adaptation of the material. Then followed by conventional glass ionomer cement then by amalgam (followed by fissure sealant at the margins).

Group 3: Pulpotomy (CH); n = 48 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed, followed by slow‐speed bur

• Pulpotomy amputation with high speed followed by excavator

• Haemostasis with saline‐moistened sterile cotton pellets for two to four minutes

• Irrigation with saline

• Calcium hydroxide powder mixed with sterile water in a 3:1 ratio to produce a homogeneous paste. The material was placed in the pulp chamber as described for groups 1 and 2.

• Then followed by conventional glass ionomer cement then by amalgam (followed by fissure sealant at the margins).

Outcomes

Clinical success (absence of spontaneous pain and/ or sensitivity to palpation/percussion; absence of fistula, swelling, and/or abnormal mobility), radiological success (absence of radiolucencies at the inter‐radicular and/or periapical regions, absence of pulp canal obliteration (fully obliterated canals); and absence of internal or external (pathologic) resorption), defective restoration (clinically): evaluation at 1, 3, 6, 12, 18, 24 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Low risk

Quote: "...sequentially numbered opaque‐sealed envelopes"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Quote: "Operator blinding was not possible"

Blinding of clinical outcomes assessment

Low risk

Quote: "Two calibrated operators, blinded to group assignment and treatment, performed ...clinical ...recall examinations"

Blinding of radiological outcomes assessment

Low risk

Quote: "Two calibrated operators, blinded to group assignment and treatment, performed ...radiographic recall examinations"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Proportion of missing outcomes < 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in India. Operator not mentioned.

Participants

52 children, 60 teeth, 3.8 to 7.6 years

Interventions

Group 1: Pulpectomy (ozonated oil‐ZO); n = 30 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access

• Pulpotomy amputation not mentioned

• Instrumentation with barbed broaches and K‐files

• Irrigation with 2.5 % sodium hypochlorite and normal saline

• The root canals were filled 1 mm short of the apex with a mixture of ZO powder (0.2 g, arsenic free) and ozonated sesame oil using Lentulo spirals, before being restored with stainless steel crowns

Group 2: Pulpectomy (ZOE); n = 30 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access

• Pulpotomy amputation not mentioned

• Instrumentation with barbed broaches and K‐files

• Irrigation with 2.5 % sodium hypochlorite and normal saline

• The root canals were filled 1 mm short of the apex with ZOE using Lentulo spirals, before being restored with stainless steel crowns

Outcomes

Clinical success (absence of pain, tenderness to percussion, absence or decrease in mobility and sinus opening), radiographic success (signs of resolution in the radiolucency, no new signs of post‐operative radiolucency and no signs of internal or external pathological root resorption), radiographic failure (increase in postoperative inter‐radicular radiolucency or development of new postoperative radiolucency): evaluation at 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "The teeth were evaluated for success or failure based on clinical and radiographic criteria by a blinded investigator"

Blinding of radiological outcomes assessment

Low risk

Quote: "The teeth were evaluated for success or failure based on clinical and radiographic criteria by a blinded investigator"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Department of Pediatric Dentistry, First Dental Center, Peking University School and Hospital of Stomatology, Beijing, China. Operator was one investigator

Participants

155 children, 160 teeth, average age: 5.88 ± 1.27 years

Interventions

Group 1: Pulpectomy (ZOE); n = 51 (2 visits)

• Rubber dam

• Instrumentation with files

• Irrigation with 2,5% hypochlorite

• Canal dried with sterile paper points

Group 2: Pulpectomy (Vitapex); n = 56 (2 visits)

• Rubber dam

• Instrumentation with files

• Irrigation with 2,5% hypochlorite

• Canal dried with sterile paper points

Group 3: Pulpectomy (MPRCF); n = 53 (2 visits)

• First visit

• Rubber dam

• Instrumentation with files

• Irrigation with 2,5% hypochlorite

• Canal dried with sterile paper points

• Calcium hydroxide placed into root canals

• Temporary restoration with Cavit

• Second visit (if signs or symptoms)

• Canal filled with MPRCF

• Adhesive restoration: Lime light (Pulpdent), Adper easy one bond (3M), Filtek Z250 (3M)

Outcomes

Clinical and radiologic success: evaluation at 6 and 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "...the clinical ...diagnoses were blindly assessed by other two investigators"

Blinding of radiological outcomes assessment

Low risk

Quote: "...the ...radiogaphic diagnoses were blindly assessed by other two investigators"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the University Center Heminio Ometto, School of  Dentistry, Araras, Sao Paulo, Brazil. Operators not mentioned

Participants

29 children, 51 teeth, age range 4.5 to 6.5 years

Interventions

Group 1: Pulpotomy (formocresol); n = 28 (4 visits)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, dry cotton pellet

• Irrigation with 0.5% saline

• Pulpotomy, FC used. "The cavity was provisionally restored with an IRM …After 7 days, …the FC dressing was changed, and the cavity was sealed with an IRM again. After another 7 days, …the dressing was removed and the coronal chamber was restored with a slow‐setting pure ZOE. The tooth was sealed with IRM. One month later, the treated primary molars were restored with a glass‐ionomer cement …If the restoration was not satisfactory, it was substituted with a performed stainless steel crown"

Group 2: Pulpectomy (calcium hydroxide); n = 23 (4 visits)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet with saline

• Irrigation with 0.5% saline

• Instrumentation with endodontic files

• Pulpectomy then CH

• "The tooth was temporarily sealed with an IRM …placed over a cotton pellet... After 7 days …a new calcium hydroxide paste dressing was introduced …and the tooth was temporarily sealed again. After an additional 7 days, definitive obturation of the canals was performed with calcium hydroxide paste …thickened with calcium hydroxide powder …and the tooth was sealed with IRM"

• "One month later, the treated primary molars were restored with a glass‐ionomer cement …If the restoration was not satisfactory, it was substituted with a performed stainless steel crown"

Outcomes

No data provided

Notes

Dropouts: no information provided

Follow‐up for 48 months; reporting at baseline, 12, 24, 26, 48 months

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Department of Paediatric Dentistry at the Universitat Internacional de Catalunya, Spain. Operator was a postgraduate student

Participants

68 children, 90 teeth, age range 4 to 9 years, mean 6.6 ± 1.3 years

Interventions

Group 1: Pulpotomy (MTA); n = 45 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur followed by slow speed bur

• Pulpotomy amputation with slow speed bur

• For haemostasis, sterile cotton pellet moistened with saline solution

• Irrigation not mentioned

• mixing MTA powder with sterile saline in a ratio of 3:1, IRM, stainless steel crown

Group 2: Pulpotomy (Biodentine); n = 45 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur followed by slow speed bur

• Pulpotomy amputation with slow speed bur

• For haemostasis, sterile cotton pellet moistened with saline solution

• Irrigation not mentioned

• mixing Biodentine powder with a single dose of liquid, IRM, stainless steel crown

Outcomes

Clinical success (no symptoms of pain, and there was no swelling or gingival inflammation, fistulation, or pathologic mobility), radiologic success (no evidence of internal or external resorption or periradicular radiolucency): evaluation at 6 and 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups

Selective reporting (reporting bias)

Low risk

Protocol prospectively registered (NCT01591278). no discrepancies in outcomes between registered record and published RCT.

Methods

RCT, parallel‐arm

Children randomly assigned

Conducted in the dental clinics of the Indiana University Institutional Review Board, USA. Operators were investigators: "...standardization of the investigators in the experimental technique was attempted by using a clinician with over 20 years of experience in performing the electrosurgical…"

Participants

50 children, 50 teeth mean age 5.3 years, age range 2.2 to 8.1 years

Interventions

Group 1: Pulpotomy (formocresol); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator, slow‐speed bur, or both

• For haemostasis, dry cotton pellet

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crown

Group 2: Pulpotomy (electrosurgery); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator, slow‐speed bur, or both

• For haemostasis, dry cotton pellet

• No irrigation

• Pulpotomy, haemorrhage control with sterile cotton wool pellet and electrosurgery to pulp stumps. Maximum of 3 applications of 1 second to each pulpal orifice, with cool‐down periods of 5 seconds between applications to limit heat build‐up. Unit at 40% power. Followed by IRM dressings before being restored with stainless‐steel crown

Outcomes

Clinical success (no pain, no abscess, no fistula or no excessive mobility), radiological success (normal periodontal ligament space, no pathological root resorption, no canal calcification and no periradicular radiolucency): mean evaluation at 11.5 (range 5‐25) months for Group 1 and 10.9 (6‐31) for Group 2 (at tooth level)

Notes

Source of funding: quote: "This study was supported by Birtcher Medical Services, Inc"
Comment: Birtcher Medical Systems, Inc. is a USA manufacturer of medical and surgical instruments

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "...the patients were assigned randomly by the flip of a coin"

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing outcome data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Setting not mentioned. Conducted in Turkey. Operators were investigators

Participants

67 children, 100 teeth, age range 5 to 9 years

Interventions

Group 1: Direct pulp capping (calcium hydroxide); n = 20 (1 visit)

• Rubber dam not mentioned

• Caries removal prior to pulpal access

• Pulp access not mentioned

• No pulpotomy amputation

• For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure"

• Irrigation with saline

• Direct pulp capping. CH cement "a non‐gamma II type amalgam was placed into the cavity in small increments with special care not to damage the CH cement during condensation. After occlusal adjustments and burnishing, the tooth‐amalgam margins were etched with 37% phosphoric acid for 30 seconds, rinsed with water for 15 seconds; dried and sealed with a light‐cured fissure sealant material to prevent short‐term microleakage that could affect healing"

Group 2: Direct pulp capping (acetone‐based total‐etch adhesive); n = 20 (1 visit)

• Rubber dam not mentioned

• Caries removal prior to pulpal access

• Pulp access not mentioned

• No pulpotomy amputation

• For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure"

• Irrigation with saline

• Acetone‐based total‐etch adhesive. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"

Group 3: Direct pulp capping (acetone‐based total‐etch adhesive ‐ non rinse conditioner); n = 20 (1 visit)

• Rubber dam not mentioned

• Caries removal prior to pulpal access

• Pulp access not mentioned

• No pulpotomy amputation

• For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure"

• Irrigation with saline

• Non‐rinse conditioner. Then treatment 2. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"

Group 4: Direct pulp capping (acetone‐based total‐etch adhesive ‐ total etching); n = 20 (1 visit)

• Rubber dam not mentioned

• Caries removal prior to pulpal access

• Pulp access not mentioned

• No pulpotomy amputation

• For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure"

• Irrigation with saline

• Total‐etching with 36% phosphoric acid. 36% phosphoric acid gel on enamel margins for 15 seconds followed by extending gel application to the cavity for an additional 10 seconds with care not to contact the exposed pulp. Then treatment 2. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"

Group 5: Direct pulp capping (acetone‐based total‐etch adhesive ‐ self‐etch); n = 20 (1 visit)

• Rubber dam not mentioned

• Caries removal prior to pulpal access

• Pulp access not mentioned

• No pulpotomy amputation

• For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure"

• Irrigation with saline

• Self‐etch adhesive system. Then treatment 2. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"

Outcomes

Clinical success (no spontaneous pain or sensitivity (or both) to pressure/percussion, no fistula, oedema, abnormal mobility, or a combination), radiological success (no radiolucency at the inter‐radicular or periapical regions (or both), no internal or external (pathological) resorption that was not compatible with the expected resorption due to the exfoliation process), inter‐radicular radiolucency or periapical radiolucency, internal root resorption or external root resorption, pain symptoms or spontaneous pain: evaluation at 1, 3, 6, 9, 12, 18 and 24 months (at tooth level)

Notes

Reasons for dropouts: 9 exfoliations (7 at 18 months, 2 at 24 months); 2 extractions (12 and 18 months), 1 extraction (6 months), 1 extraction (12 months)

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "...two calibrated operators, blinded to the treatments, performed the clinical ...recall examinations"

Blinding of radiological outcomes assessment

Low risk

Quote: "...two calibrated operators, blinded to the treatments, performed the ...radiological recall examinations"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Proportion of missing outcomes < 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Hospital for Sick Children, Toronto, Canada. Operators were 3 paediatric dentists

Participants

112 children, 266 teeth, mean age 4.0 years, standard deviation age 1.1 years

Interventions

Group 1: Pulpotomy (FS + eugenol); n = 58 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed followed by slow speed

• Pulpotomy amputation with slow speed

• For haemostasis saline ‐ water flush

• No irrigation

• 15.5% aqueous FS solution was gently burnished with the syringe applicator for 15 seconds after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crown

Group 2: Pulpotomy (FS); n = 78 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed followed by slow speed

• Pulpotomy amputation with slow speed

• For haemostasis saline ‐ water flush

• No irrigation

• Eugenol‐free FS. 15.5% aqueous FS solution was gently burnished with the syringe applicator for 15 seconds after pulpotomy, followed by Cimpact S dressings before being restored with stainless‐steel crown

Group 3: Pulpotomy (MTA); n = 53 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed followed by slow speed

• Pulpotomy amputation with slow speed

• For haemostasis, saline ‐ water flush

• No irrigation

• MTA (3:1 powder:water ratio) placed on pulp stumps after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crown

Group 4: Pulpotomy (MTA + FS + eugenol); n = 77 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high speed followed by slow speed

• Pulpotomy amputation with slow speed

• For haemostasis saline ‐ water flush

• No irrigation

• FS: MTA. 15.5% aqueous FS solution was gently burnished with the syringe applicator then MTA 3:1 for 15 seconds after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crown

Outcomes

Tenderness to percussion, pathological mobility, erythema, parulis, pathological radiolucency, internal root resorption, external root resorption, periodontal ligament widening, pulp canal obliteration, N (score 5‐rx), Po (score 5‐rx), Px (score 5‐rx): mean evaluation at 22 (range 6 to 38) months (at tooth level)

Quote: "Subjects were invited to return for clinical and radiographic assessments at 12, 24, and 36 months after treatment"

Notes

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer‐generated random numbers table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Low risk

Quote: "2 blinded, disinterested raters classified each molar into 1 of 3 radiographic outcomes"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the University of Marmara, Department of Paediatric Dentistry, in Istanbul. Operator was one paediatric dentist.

Participants

58 children, 120 teeth, age range 5 to 9 years

Interventions

Group 1: Pulpotomy (diode laser); n = 40 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access not mentioned

• Pulpotomy amputation with slow speed followed by excavator

• For haemostasis, dry cotton pellet

• Irrigation not mentioned

• A DL beam at a wavelength of 810 nm was transmitted. The DL fibre tip was kept 1–2mm from touching the tissue. The pulp at canal orifices was exposed with parameters of a frequency of 30 Hz and energy of 50 mJ, with a power of 1.5 W for 10 sec with air‐cooling operation mode without water. Followed by ZOE followed by glass ionomer cement before being restored with stainless‐steel crown

Group 2: Pulpotomy (formocresol); n = 40 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access not mentioned

• Pulpotomy amputation with slow speed followed by excavator

• For haemostasis, dry cotton pellet

• Irrigation not mentioned

• cotton pellet placed directly over the radicular pulp stumps and left for 5 min for fixation, followed by ZOE followed by glass ionomer cement before being restored with stainless‐steel crown

Group 3: Pulpotomy (ferric sulphate); n = 40 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access not mentioned

• Pulp access not mentioned

• Pulpotomy amputation with slow speed followed by excavator

• For haemostasis, dry cotton pellet

• Irrigation not mentioned

• FS applied by wiping the cotton tip on the pulp stumps for 15 sec. The pulp cavity was washed with saline to remove any blood clot particles, followed by ZOE followed by glass ionomer cement before being restored with stainless‐steel crown

Outcomes

Clinical failure (spontaneous pain, percussion/palpation, abscess, swelling, fistula, or pathologic mobility), radiological failure (periapical radiolucency, widened periodontal ligament space (PDL), pathologic internal/external root resorption, or pathological changes of the alveolar bone in the furcation): evaluation at 1, 3, 6, 9, and 12 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "The outcome assessment and data analysis were blinded "

Blinding of radiological outcomes assessment

Unclear risk

Quote: "The outcome assessment and data analysis were blinded " BUT "Two blinded observers evaluated a set of radiographs separately"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the undergraduate and graduate Pediatric Dentistry Clinics of the Hebrew University‐Hadassah School of Dental Medicine, Israel. Operators were authors

Participants

26 children, 45 teeth; 32 teeth from 18 children analysed, mean age 6.4 years, age range 5 to 12 years

Interventions

Group 1: Pulpotomy (formocresol); n = 17 teeth (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• Haemostasis not mentioned

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM dressings before being restored with stainless‐steel crown

Group 2: Pulpotomy (MTA); n = 15 teeth (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• Haemostasis not mentioned

• No irrigation

• MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crowns

Outcomes

Signs of failure (internal root resorption, furcation radiolucency, periapical bone destruction, pain, swelling, or sinus tract), internal root resorption, furcation radiolucency, periapical bone destruction, pain, swelling, or sinus tract: evaluation at 13 (6 to 30) months (at tooth level)

Notes

Reasons of dropouts: quotes: "a total of 45 primary molars were pulpotomized in 26 children. Of these 32 teeth in 18 children were available for follow‐up evaluation"; "4 children with 8 teeth had less than 6 months postoperative period at the time of data analysis. 3 children with 5 teeth were not available for follow‐up examination since they moved to another city"

Source of funding: not reported, although the MTA material was provided by a colleague at another university in the USA

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Coin toss

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement of Yes or No

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement of Yes or No

Blinding of clinical outcomes assessment

High risk

Quote: "the children were examined clinically at follow‐up by one of the 3 authors who were not blind to which treatment group the subject belong"

Blinding of radiological outcomes assessment

Low risk

Quote: "all 3 authors blindly evaluated the radiographs"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, split‐mouth

Teeth randomly assigned

Conducted at the Pediatric Dental Clinics, Faculty of Dentistry, King Abdulaziz University (KAU), Jeddah. Operators not mentioned

Participants

37 children, 56 pairs, 112 teeth; mean age 6 ± 0.75 years, age range 4 to 8 years

Interventions

Group 1: Pulpotomy (formocresol); n = 56 teeth (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• Haemostasis with sterile wet cotton pellet

• Irrigation with normal saline

• Cotton wool pellet soaked with 1:5 diluted FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM dressings before being restored with stainless‐steel crown

Group 2: Pulpotomy (Biodentine); n = 56 teeth (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• Haemostasis with sterile wet cotton pellet

• Irrigation with normal saline

• Biodentine before being restored with stainless‐steel crown

Outcomes

Clinical success (absence of sensitivity, pain, or swelling, no tenderness to percussion, no abscess or fistulation, no tooth mobility), radiographic success (absence of furcation and periapical radiolucency, absence of internal or external root resorption), presence of a normal periodontal ligament space, presence of pulp canal obliteration: evaluation at 3 and 6 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement of Yes or No

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement of Yes or No

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement of Yes or No

Blinding of clinical outcomes assessment

Low risk

Quote: "Independently, two examiners who were blinded to treatment type evaluated the teeth clinically and radiographically."

Blinding of radiological outcomes assessment

Low risk

Quote: "Independently, two examiners who were blinded to treatment type evaluated the teeth clinically and radiographically."

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel arm

Teeth randomly assigned

Setting not mentioned. Conducted in Turkey. Operators were 3 paediatric dentists

Participants

32 children, 100 teeth, mean age 6.2 years, standard deviation age 0.7 years. age range 5 to 7 years

Interventions

Group 1: Pulpotomy (MTA); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access not mentioned

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet

• Irrigation with saline

• MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by ZOE dressings before being restored with stainless‐steel crowns

Group 2: Pulpotomy (ferric sulphate); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access not mentioned

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet

• Irrigation with saline

• 15.5% FS solution applied for 15 seconds after pulpotomy, followed by ZOE dressings before being restored with amalgam

Group 3: Pulpotomy (formocresol); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access not mentioned

• Pulpotomy amputation with excavator

• For haemostasis, moistened cotton pellet

• Irrigation with saline

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE dressings before being restored with amalgam

Group 4: n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access not mentioned

• Pulpotomy amputation with excavator

• For haemostasis, dry moistened cotton pellet

• Irrigation with saline

• ZOE applied after pulpotomy dressings before being restored with amalgam

Outcomes

Clinical failure (pain, swelling, mobility, percussion pain), radiological failure (internal root resorption, and furcation or periapical bone destruction (or both)), signs of failure (pain, swelling, mobility, percussion pain, internal root resorption, and furcation or periapical bone destruction (or both)), internal root resorption, pulp canal obliteration, tenderness to percussion, inter‐radicular bone destruction, physiological root resorption: evaluation at 6, 12 and 24 months (at tooth level)

Notes

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "the children were examined clinically by 3 experienced pediatric dentists (not the operators) blinded to the technique"

Blinding of radiological outcomes assessment

Low risk

Quote: "the children were examined radiographically by 3 experienced pediatric dentists (not the operators) blinded to the technique"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, split‐mouth

Teeth randomly assigned

Setting not mentioned. Conducted in Iran. One operator (no detail)

Participants

21 children, 42 teeth, mean age 6.9 ± 0.7, age range 5 to 8 years

Interventions

Group 1: Direct pulp capping (MTA); n = 21 (1 visit)

• cotton rolls and suction

• Caries removal prior to pulpal access

• high speed and carbide round bur

• For haemostasis, dry cotton pellet

• Irrigation with saline

• ProRoot MTA before being restored with amalgam

Group 2: Direct pulp capping (CEM); n = 21 (1 visit)

• cotton rolls and suction

• Caries removal prior to pulpal access

• high speed and carbide round bur

• For haemostasis, dry cotton pellet

• Irrigation with saline

• CEM before being restored with amalgam

Outcomes

Clinical failure (pain, swelling, tenderness to pressure, sinus tract, swelling and tenderness to percussion), radiological failure (internal and/or external root resorption, interradicular radiolucencies, and periapical lesions): evaluation at 6 and 20 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

The single operator and children were blind to biomaterial/treatment

Blinding of clinical outcomes assessment

Low risk

Quote: "Treatment outcomes ...were evaluated at 20 months by a calibrated dentist, radiologist and a statistician who were also blind to the type of used biomaterial"

Blinding of radiological outcomes assessment

Low risk

Quote: "Treatment outcomes ...were evaluated at 20 months by a calibrated dentist, radiologist and a statistician who were also blind to the type of used biomaterial"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Proportion of missing outcomes < 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Children randomly assigned

Setting not mentioned. Operators were paediatric dentists. Conducted in Saudi Arabia

Participants

100 children, 120 teeth, mean age 6 years, standard deviation age 1.6 years, age range 3 to 8 years

Interventions

Group 1: Pulpotomy (formocresol); n = 60 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• For haemostasis, damp sterile cotton pellet

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM before being restored with stainless‐steel crowns

Group 2: Pulpotomy (MTA); n = 60 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation not mentioned

• For haemostasis, damp sterile cotton pellet

• No irrigation

• MTA (3:1 powder:saline ratio) applied after pulpotomy, followed by IRM before being restored with stainless‐steel crowns

Outcomes

Clinical success (no pain, sinus tract or swelling), radiographic success (no evidence of furcation radiolucency, internal root resorption, or periapical bone destruction), physiological root resorption, furcation radiolucency, periapical radiolucency, internal root resorption, pulp canal obliteration, pain symptoms, sinus tract, swelling: evaluation at 6, 12, 18 and 24 months (at tooth level)

Notes

Dropouts: "Out of 120 teeth, only 74 were assessed clinically and radiographically throughout the follow up period"

Comment: only the results for these 74 teeth were reported

Source of funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Coin toss

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Incomplete outcome data (attrition bias)
All outcomes

High risk

Proportion of missing outcomes > 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Pediatric Dental Clinic at the University of Southern California School of Dentistry. Operators not mentioned

Participants

62 children, 83 teeth, mean age 6.7 years, age range 3.2 to 10.1 years

Interventions

Group 1: Pulpotomy (formocresol); n = not stated (27 teeth analysed) (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator or slow‐speed bur

• For haemostasis, dry cotton pellet

• No irrigation

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM before being restored with stainless‐steel crowns

Group 2: Pulpotomy (ferric sulphate); n = not stated (29 teeth analysed) (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator or slow‐speed bur

• For haemostasis, dry cotton pellet

• No irrigation

• 15.5% FS solution applied after pulpotomy, followed by ZOE and IRM before being restored with stainless‐steel crowns

Outcomes

Clinical success (no symptoms of pain, tenderness to percussion, swelling, fistulation or pathological tooth mobility), radiographic success (normal periodontal ligament, absence of pathological internal root resorption, external root resorption, no intraradicular or no periapical radiolucency), signs of failure (symptoms of pain, tenderness to percussion, swelling, fistulation, pathological tooth mobility, abnormal periodontal ligament, pathological internal root resorption, external root resorption, intraradicular or periapical radiolucency), internal root resorption, pulp canal obliteration: evaluation at 3, 6 and 12 months (at tooth level)

Notes

56 teeth from 48 children were available for evaluation after 12 months (Group 1: 27; Group 2: 29)

Source of funding: not reported, although FS material was provided by a manufacturer
Quote: "The ferric sulphate tested in this study was provided by the Ultradent Company"

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random numbers table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "Clinical evaluations of the teeth were conducted by two independent examiners who had no knowledge of the group to which the particular tooth was assigned"

Blinding of radiological outcomes assessment

Low risk

Quote: "Radiological evaluations of the teeth were conducted by two independent examiners who had no knowledge of the group to which the particular tooth was assigned"

Incomplete outcome data (attrition bias)
All outcomes

High risk

Number of randomised teeth unknown

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Children randomly assigned

Setting not mentioned. Operators not mentioned. Conducted in Brazil

Participants

number of children not mentioned, 60 teeth, mean age 6.5 years, age range 5 to 9 years

Interventions

Group 1: Pulpotomy (formocresol); n = 15 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, dry sterile cotton pellet

• Irrigation with saline

• Cotton wool pellet soaked with 1:5 FC placed on pulp stumps for 5 minutes after pulpotomy, followed by ZOE and IRM before being restored with glass ionomer cement

Group 2: Pulpotomy (CH); n = 15 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, dry sterile cotton pellet

• Irrigation with saline

• CH, followed by ZOE and IRM before being restored with glass ionomer cement

Group 3: Pulpotomy (LLLT); n = 15 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, dry sterile cotton pellet

• Irrigation with saline

• the InGaAlP laser radiation was delivered through a 320 lm diameter optical fibre in contact with pulp tissue; the parameters were set at 660 nm wavelength, 10 mW power output, 2.5 J/cm² energy density, 50 to 60 Hz frequency, 0.04 cm² focus beam diameter and irradiation time of 10 seconds, followed by ZOE and IRM before being restored with glass ionomer cement

Group 4: Pulpotomy (CH+ LLLT); n = 15 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur

• Pulpotomy amputation with excavator

• For haemostasis, dry sterile cotton pellet

• Irrigation with saline

• the InGaAlP laser radiation was delivered through a 320 lm diameter optical fibre in contact with pulp tissue; the parameters were set at 660 nm wavelength, 10 mW power output, 2.5 J/cm² energy density, 50 to 60 Hz frequency, 0.04 cm² focus beam diameter and irradiation time of 10 seconds, followed by CH, then IRM before being restored with glass ionomer cement

Outcomes

Clinical success (absence of spontaneous pain, mobility, swelling, or fistula), Radiographic success (presence of hard tissue barrier formation and pulp calcifications, and absence of internal or external root resorption and furcation radiolucency)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Low risk

Quote: "At each checkup, two blinded and calibrated investigators performed clinical and periapical radiographic examination of the pulpotomized teeth"

Blinding of radiological outcomes assessment

Low risk

quote: "At each checkup, two blinded and calibrated investigators performed clinical and periapical radiographic examination of the pulpotomized teeth"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Proportion of missing outcomes < 10% of children randomly assigned

Selective reporting (reporting bias)

Unclear risk

Insufficient information to make a clear judgement

Methods

RCT, parallel‐arm

Teeth randomly assigned

Conducted in the Department of Paediatric Dentistry at the Universitat Internacional de Catalunya. Operators were student and dentists.

Participants

81 children, 100 teeth, mean age 6.7 ± 1.6 years, age range 3.2 to 10.1 years

Interventions

Group 1: Pulpotomy (formocresol); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur the slow‐speed bur

• Pulpotomy amputation with slow‐speed bur

• For haemostasis, moist cotton pellet with saline

• Irrigation not mentioned

• Cotton wool pellet soaked with FC placed on pulp stumps for 5 minutes after pulpotomy, followed by IRM before being restored with stainless‐steel crowns

Group 2: Pulpotomy (MTA); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur the slow‐speed bur

• Pulpotomy amputation with slow‐speed bur

• For haemostasis, moist cotton pellet with saline

• Irrigation not mentioned

• MTA paste obtained by mixing MTA powder with sterile saline in a ratio of 3 : 1, followed by IRM before being restored with stainless‐steel crowns

Group 3: Pulpotomy (ferric sulphate); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur the slow‐speed bur

• Pulpotomy amputation with slow‐speed bur

• For haemostasis, moist cotton pellet with saline

• Irrigation not mentioned

• 20% FS solution applied after pulpotomy for 15 seconds with syringe applicator (then solution was rinsed off with water, verifying that no blood clot was present before restoration), followed by IRM before being restored with stainless‐steel crowns

Group 4: Pulpotomy (sodium hypochlorite); n = 25 (1 visit)

• Rubber dam

• Caries removal prior to pulpal access

• Pulp access with high‐speed bur the slow‐speed bur

• Pulpotomy amputation with slow‐speed bur

• For haemostasis, moist cotton pellet with saline

• Irrigation not mentioned

• cotton pellet saturated in 5% NaOCl was placed over the remaining pulp tissue for 30 seconds (then the solution was rinsed off with water, verifying that no blood clot was present before restoration), followed by IRM before being restored with stainless‐steel crowns

Outcomes

Clinical success (no pain, swelling, fistulation, or pathologic mobility), radiographic success (no evidence of internal or external resorption, or periradicular radiolucency), overall success: evaluation at 6, 12, 18, and 24 months

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random number table

Allocation concealment (selection bias)

Unclear risk

Insufficient information to make a clear judgement

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Insufficient information to make a clear judgement

Blinding of clinical outcomes assessment

Unclear risk

Insufficient information to make a clear judgement

Blinding of radiological outcomes assessment

Low risk

Quote: "the radiographs were ...re‐evaluated independently by two blinded observers"