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Recubrimiento para las caries dentales en las restauraciones de clase I y clase II con composite basado en resina

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References

References to studies included in this review

Akpata 2001 {published data only}

Akpata ES, Sadiq W. Post‐operative sensitivity in glass‐ionomer versus adhesive resin‐lined posterior restorations. American Journal of Dentistry 2001;14(1):34‐8. CENTRAL

Banomyong 2013 {published data only}

Banomyong D, Harnirattisai C, Burrow MF. Posterior resin composite restorations with or without resin‐modified, glass‐ionomer cement lining: a 1‐year randomised, clinical trial. Journal of Investigative and Clinical Dentistry 2011;2(1):63‐9. CENTRAL
Banomyong D, Messer, H. Two‐year clinical study on postoperative pulpal complications arising from the absence of a glass‐ionomer lining in deep occlusal resin‐composite restoration. Journal of Investigative and Clinical Dentistry 2013;4(4):265‐70. CENTRAL

Boeckler 2012 {published data only}

Boeckler A, Schaller H‐G, Gernhardt CR. A prospective, double‐blind, randomized clinical trial of a one‐step, self‐etch adhesive with and without an intermediary layer of a flowable composite: a 2‐year evaluation. Quintessence International 2012;43(4):279‐86. CENTRAL

Browning 2006 {published data only}

Browning WD, Myers ML, Chan DC, Downey MC, Pohjola RM, Frazier KB. Performance of 2 packable composites at 12 months. Quintessence International 2006;37(5):361‐8. CENTRAL

Burrow 2009 {published data only}

Burrow MF, Banomyong D, Harnirattisai C, Messer HH. Effect of glass‐ionomer cement lining on postoperative sensitivity in occlusal cavities restored with resin composite ‐ a randomized clinical trial. Operative Dentistry 2009;34(6):648‐55. CENTRAL

Efes 2006 {published data only}

Efes BG, Dorter C, Gomec Y, Koray F. Two‐year clinical evaluation of ormocer and nanofill composite with and without a flowable liner. Journal of Adhesive Dentistry 2006;8(2):119‐26. CENTRAL

Strober 2013 {published data only}

Strober B, Veitz‐Keenan A, Barna JA, Matthews AG, Vena D, Craig RG, et al. Effectiveness of a resin‐modified glass ionomer liner in reducing hypersensitivity in posterior restorations: A study from the Practitioners Engaged in Applied Research and Learning Network. Journal of the American Dental Association 2013;144(8):886‐97. CENTRAL

Wegehaupt 2009 {published data only}

Wegehaupt F, Betke H, Solloch N, Musch U, Wiegand A, Attin T. Influence of cavity lining and remaining dentin thickness on the occurrence of postoperative hypersensitivity of composite restorations. Journal of Adhesive Dentistry 2009;11(2):137‐41. CENTRAL

References to studies excluded from this review

Akpata 2006 {published data only}

Akpata ES, Behbehani J. Effect of bonding systems on post‐operative sensitivity from posterior composites. American Journal of Dentistry 2006;19(3):151‐4. CENTRAL

Andersson‐Wenckert 2002 {published data only}

Andersson‐Wenckert IE, van Dijken JW, Horstedt P. Modified Class II open sandwich restorations: evaluation of interfacial adaptation and influence of different restorative techniques. European Journal of Oral Sciences 2002;110(3):270‐5. CENTRAL

Andersson‐Wenckert 2004 {published data only}

Andersson‐Wenckert IE, van Dijken JW, Kieri C. Durability of extensive Class II open‐sandwich restorations with a resin‐modified glass ionomer cement after 6 years. American Journal of Dentistry 2004;17:43‐50. CENTRAL

Ernst 2002 {published data only}

Ernst CP, Buhtz C, Rissing C, Willershausen B. Clinical performance of resin composite restorations after 2 years. Compendium of Continuing Education in Dentistry 2002;23(8):711‐4. CENTRAL

Ernst 2003 {published data only}

Ernst CP, Canbek K, Aksogan K, Willershausen B. Two‐year clinical performance of a packable posterior composite with and without a flowable composite liner. Clinical Oral Investigations 2003;7(3):129‐34. CENTRAL

Fagundes 2009 {published data only}

Fagundes TC, Barata TJ, Carvalho CA, Franco EB, van Dijken JW, Navarro MF. Clinical evaluation of two packable posterior composites: a five‐year follow‐up. Journal of the American Dental Association 2009;140(4):447‐54. CENTRAL

Grogono 1990 {published data only}

Grogono AL, McInnes PM, Zinck JH, Weinberg R. Posterior composite and glass ionomer/composite laminate restorations: 2‐year clinical results. American Journal of Dentistry 1990;3(4):147‐52. CENTRAL

Huth 2003 {published data only}

Huth KC, Manhard J, Hickel R, Kunzelmann KH. Three‐year clinical performance of a compomer in stress‐bearing restorations in permanent posterior teeth. American Journal of Dentistry 2003;16(4):255‐9. CENTRAL

Kaurani 2007 {published data only}

Kaurani M, Bhagwat SV. Clinical evaluation of postoperative sensitivity in composite resin restorations using various liners. New York State Dental Journal 2007;73(2):23‐9. CENTRAL

Knibbs 1992 {published data only}

Knibbs PJ. The clinical performance of a glass polyalkenoate (glass ionomer) cement used in a 'sandwich' technique with a composite resin to restore Class II cavities. British Dental Journal 1992;172(3):103‐7. CENTRAL

Loguercio 2001 {published data only}

Loguercio AD, Reis A, Rodrigues Filho LE, Busato AL. One‐year clinical evaluation of posterior packable resin composite restorations. Operative Dentistry 2001;26:427‐34. CENTRAL

Noro 1983 {published data only}

Noro A, Ishikawa T. A clinico‐pathological study of pulp response of a restoration system with ultraviolet‐light polymerised resin and the effectiveness of several lining materials. Bulletin of the Tokyo Dental College 1983;24(2):61‐77. CENTRAL

Rasmusson 1998 {published data only}

Rasmusson CG, Kohler B, Odman P. A 3‐year clinical evaluation of two composite resins in class‐II cavities. Acta Odontologica Scandinavica 1998;56(2):70‐5. CENTRAL

Shi 2010 {published data only}

Shi L, Wang X, Zhao Q, Zhang Y, Zhang L, Ren Y, et al. Evaluation of packable and conventional hybrid resin composites in Class I restorations: three‐year results of a randomized, double‐blind and controlled clinical trial. Operative Dentistry 2010;35(1):11‐9. CENTRAL

Unemori 2001 {published data only}

Unemori M, Matsuya Y, Akashi A, Goto Y, Akamine A. Composite resin restoration and postoperative sensitivity: clinical follow‐up in an undergraduate program. Journal of Dentistry 2001;29(1):7‐13. CENTRAL

van Dijken 1999 {published data only}

van Dijken JW, Kieri C, Carlen M. Longevity of extensive Class II open‐sandwich restorations with a resin‐ modified glass‐ionomer cement. Journal of Dental Research 1999;78:1319‐25. CENTRAL

Vilkinis 2000 {published data only}

Vilkinis V, Horsted‐Bindslev P, Baelum V. Two‐year evaluation of class II resin‐modified glass ionomer cement/composite open sandwich and composite restorations. Clinical Oral Investigations 2000;4:133‐9. CENTRAL

Whitworth 2005 {published data only}

Whitworth JM, Myers PM, Smith J, Walls AW, McCabe JF. Endodontic complications after plastic restorations in general practice. International Endodontic Journal 2005;38(6):409‐16. CENTRAL

Banomyong 2011

Banomyong D, Harnirattisai C, Burrow MF. Posterior resin composite restorations with or without resin‐modified, glass‐ionomer cement lining: a 1‐year randomised, clinical trial. Journal of Investigative and Clinical Dentistry 2011;2(1):63‐9.

Black 1924

Black GV, Black AD. The Pathology of the Hard Tissues of the Teeth. Vol. 1, Chicago: Medico‐Dental Publishing Company, 1924.

Briso 2007

Briso AL, Mestrener SR, Delício G, Sundfeld RH, Bedran‐Russo AK, de Alexandre RS, et al. Clinical assessment of postoperative sensitivity in posterior composite restorations. Operative Dentistry 2007;32(5):421‐6.

Castillo‐de Oyagüe 2012

Castillo‐de Oyagüe R, Lynch C, McConnell R, Wilson N. Teaching the placement of posterior resin‐based composite restorations in Spanish dental schools. Medicina Oral, Patología Oral, y Cirugía Bucal 2012;17(4):e661‐8.

Deliperi 2002

Deliperi S, Bardwell DN. An alternative method to reduce polymerization shrinkage in direct posterior composite restorations. Journal of the American Dental Association 2002;133(10):1387‐98.

Demarco 2012

Demarco FF, Corrêa MB, Cenci MS, Moraes RR, Opdam NJ. Longevity of posterior composite restorations: not only a matter of materials. Dental Materials 2012;28(1):87‐101.

Diehnelt 2001

Diehnelt DE, Kiyak AH. Socioeconomic factors that affect international caries levels. Community Dentistry and Oral Epidemiology 2001;29(3):226‐33.

Edelstein 2006

Edelstein BL. The dental caries pandemic and disparities problem. BMC Oral Health 2006;6 Suppl 1:S2.

Fejerskov 2003

Fejerskov O, Kidd EAM, editor(s). Dental Caries: the Disease and its Clinical Management. Copenhagen: Blackwell Monksgaard, 2003.

Gordan 2000

Gordan VV, Mjör IA, Veiga Filho LC, Ritter AV. Teaching of posterior resin‐based composite restorations in Brazilian dental schools. Quintessence International 2000;31(10):735‐40.

GRADE 2004

GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ 2004;328(7454):1490.

GRADEproGDT 2014 [Computer program]

GRADE Working Group, McMaster University. GRADEproGDT. Version accessed 25 May 2016. Hamilton (ON): GRADE Working Group, McMaster University, 2014.

Harris 1863

Harris CA. Principles and Practice of Dental Surgery. 8th Edition. Philadelphia: Lindsay and Blankiston, 1863.

Hayashi 2009

Hayashi M, Seow LL, Lynch CD, Wilson NH. Teaching of posterior composites in dental schools in Japan. Journal of Oral Rehabilitation 2009;36(4):292‐8.

Higgins 2011

Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JP, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.

Liew 2011

Liew Z, Nguyen E, Stella R, Thong I, Yip N, Zhang F, et al. Survey on the teaching and use in dental schools of resin‐based materials for restoring posterior teeth. International Dental Journal 2011;61(1):12‐8.

Lynch 2006

Lynch CD, McConnell RJ, Wilson NH. Teaching the placement of posterior resin‐based composite restorations in US dental schools. Journal of the American Dental Association 2006;137(5):619‐25.

Lynch 2006a

Lynch CD, McConnell RJ, Hannigan A, Wilson NH. Teaching the use of resin composites in Canadian dental schools: how do current educational practices compare with North American trends?. Journal of the Canadian Dental Association 2006;74(4):321.

Lynch 2006b

Lynch CD, McConnell RJ, Wilson NH. Teaching of posterior composite resin restorations in undergraduate dental schools in Ireland and the United Kingdom. European Journal of Dental Education 2006;10(1):38‐43.

Lynch 2007

Lynch CD, Shortall AC, Stewardson D, Tomson PL, Burke FJ. Teaching posterior composite resin restorations in the United Kingdom and Ireland: consensus views of teachers. British Dental Journal 2007;203(4):183‐7.

Lynch 2007a

Lynch CD, McConnell RJ, Wilson NH. Trends in the placement of posterior composites in dental schools. Journal of Dental Education 2007;71(3):430‐4.

Lynch 2011

Lynch CD, Frazier KB, McConnell RJ, Blum IR, Wilson NH. Minimally invasive management of dental caries: contemporary teaching of posterior resin‐based composite placement in US and Canadian dental schools. Journal of the American Dental Association 2011;142(6):612‐20.

Murray 2001

Murray PE, About I, Franquin JC, Remusat M, Smith AJ. Restorative pulpal and repair responses. Journal of the American Dental Association 2001;132(4):482‐91.

Murray 2002

Murray PE, Windsor LJ, Smyth TW, Hafez AA, Cox CF. Analysis of pulpal reactions to restorative procedures, materials, pulp capping, and future therapies. Critical Reviews in Oral Biology and Medicine 2002;13(6):509‐20.

Murray 2002a

Murray PE, About I, Lumley PJ, Franquin JC, Remusat R, Smith AJ. Cavity remaining dentin thickness and pulpal activity. American Journal of Dentistry 2002;15(1):41‐6.

Petersen 2003

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Sadeghi 2009

Sadeghi M, Lynch CD, Wilson NH. Trends in dental education in the Persian Gulf ‐an example from Iran: contemporary placement of posterior composites. European Journal of Prosthodontics and Restorative Dentistry 2009;17(4):182‐7.

Schwendicke 2015

Schwendicke F, Gostemeyer G, Gluud C. Cavity lining after excavating caries lesions: Meta‐analysis and trial sequential analysis of randomized clinical trials. Journal of Dentistry 2015;43(11):1291‐7.

Selwitz 2007

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Unemori 2007

Unemori M, Matsuya Y, Hyakutake H, Matsuya S, Goto Y, Akamine A. Long‐term follow‐up of composite resin restorations with self‐etching adhesives. Journal of Dentistry 2007;35(6):535‐40.

Wilson 2000

Wilson NH, Mjör IA. The teaching of Class I and Class II direct composite restorations in European dental schools. Journal of Dentistry 2000;28(1):15‐21.

References to other published versions of this review

Schenkel 2013

Schenkel AB, Peltz I, Veitz‐Keenan A. Dental cavity liners for Class I and Class II resin‐based composite restorations. Cochrane Database of Systematic Reviews 2013, Issue 5. [DOI: 10.1002/14651858.CD010526]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Akpata 2001

Methods

Trial design: Split‐mouth

Location: Dental school, Saudi Arabia

Funding source: None mentioned

Participants

Inclusion criteria: Occlusal caries on contralateral posterior teeth with small or moderately large carious lesions ‐ the bucco‐lingual dimensions of each cavity were less than half the intercuspal width

Age: Males 16‐52 years

Exclusion criteria: Orofacial pain, including toothache, percussion tenderness, periapical radiolucency

Number of randomised individuals: n/a

Number of randomised teeth: 88

Number of individuals evaluated: 44

Dropouts: None

Interventions

RMGI liner under RBC restoration (no bonding agent used) compared to no liner (bonding agent only) under RBC restoration

Outcomes

Postoperative hypersensitivity as measured by CRM in time (seconds) and patient reporting

Notes

Based on these data the study authors concluded that the liner group had less sensitivity but it seems that both groups had no clinically significant sensitivity after 30 days

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "There was randomization in the selection of the right and left teeth for the adhesive or glass‐ionomer lining"

Comment: No other additional information was provided ‐ it is unclear how the randomization was performed and how easy it would have been for the operators to deviate from the randomization prescribed

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants may or may not have been blinded – no information provided. Operator was not blinded – knew which tooth received liner

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"The measurement of CRM at the recall visits was by another dentist who was unaware of the lining that the experimental teeth had received"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No participants dropped out

Selective reporting (reporting bias)

Low risk

All data reported

Other bias

High risk

A validated instrument to measure patient‐reported sensitivity was not used

Banomyong 2013

Methods

Trial design: Parallel‐group

Location: Dental school postgraduate clinic Bangkok, Thailand

Funding source: None mentioned

Participants

Inclusion criteria: At least 1 deep primary occlusal caries without other defects in a first or second permanent molar, at least 1 opposing tooth, periodontal tissues healthy or only mildly inflamed, no previous signs and symptoms of pulpal and periapical disease, preoperative sensitivity relieved immediately after removal of stimulus, and no spontaneous pain

Age: 18‐30 years

Exclusion criteria: Medical problems (unspecified), orofacial pain, other defects or restorations on the tooth, cavity depth less than 3 mm, pulpal exposure, no opposing tooth, periodontal disease, signs or symptoms of periapical or pulpal disease

Number of randomised individuals: n/a

Number of randomised teeth: 62

Number of individuals evaluated: 34

Dropouts: 19

Interventions

RMGI liner under RBC restoration compared to no liner under RBC restoration

Outcomes

Postoperative hypersensitivity as measured by patient reporting

Restoration longevity

Notes

2 different bonding agents were used, with no explanation of how the distribution was determined. A further study was identified (Banomyong 2011); authors confirmed overlap in participants between the 2013 and 2011 papers

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote: "One of the two restorative procedures was randomly allocated. Each participant was unaware of the restoration"

Comment: No other additional information provided ‐ it is unclear how the randomization was performed and how easy it was for the operators to deviate from the randomization prescribed

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants were unaware of the intervention, however, the operator and evaluator were the same person, "the operator (DB)" "all restorations were examined by one evaluator (DB)"

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Operator and evaluator were the same person, "the operator (DB)" (page 3) "all restorations were examined by one evaluator (DB)"

Incomplete outcome data (attrition bias)
All outcomes

High risk

13/31 teeth from experimental group and 6/31 teeth from control group were not included in evaluation

Selective reporting (reporting bias)

Low risk

All data reported

Other bias

Low risk

None detected

Boeckler 2012

Methods

Trial design: Split‐mouth

Location: Department of Operative Dentistry and Periodontolgy, Germany

Funding source: Ivoclar Vivadent

Participants

Inclusion criteria: Adults with 2 comparable Class I or II cavities to be restored with a dental composite; positive sensitivity and existing antagonist and neighboring teeth

Age: Not specified

Exclusion criteria: Underage, systemic diseases, allergies to 1 of the substances of content, gravidity, lactation, teeth that needed direct pulp capping, and endodontically treated teeth

Number of randomised individuals: 50

Number of randomised teeth: 100

Number of individuals evaluated: 44 (87 teeth)

Dropouts: 6

Interventions

Flowable composite Tetric EvoFlow under Tetric EvoCeram compared to Tetric EvoCeram only (both groups used adhesive system AdheSE One)

Outcomes

Postoperative hypersensitivity as measured by CRM using subjective descriptive patient‐response criteria

Modified Ryge criteria categories evaluated (color match, marginal discoloration, filing integrity, marginal adaptation, surface, secondary caries, proximal contact, and hypersensitivity)

Restoration longevity

Notes

"The sample size was determined by a statistician ....for 5% level of significance and a power of 90%"

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"...computer generated randomization list"

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants may or may not have been blinded – no information provided. Operator was not blinded – knew which tooth received liner

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"Two blinded, calibrated clinicians not involved with the treatment procedures evaluated each restoration"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All participants evaluated at 6 and 12 months. 6 participants were lost for the 2‐year evaluation due to address changes; unlikely to influence results

Selective reporting (reporting bias)

Low risk

All relevant outcomes reported

Other bias

Low risk

None detected

Browning 2006

Methods

Trial design: Parallel‐group

Location: Dental school, USA

Funding source: None mentioned

Participants

Inclusion criteria: Adults in need of only 1 moderate to large Class II or complex Class I restoration on a molar; occlusally the final margin had to extend more than halfway from the central groove to the cusp tip; interproximally, the final facial and/or lingual margin of the proximal box had to extend at least halfway between minimal clearance and the line angle; no contraindications to routine dental treatment; participant had to be likely to remain in the area for the length of the study

Age: Adults (specific age not reported)

Exclusion criteria: Removal of caries resulting in exposure of dental pulp

Number of randomised individuals: 50

Number of randomised teeth: 25 teeth in each group

Number of individuals evaluated: 44

Dropouts: 6 total ‐ 3 from each group

Interventions

Flowable liner under 1 brand RBC restoration compared to no flowable liner under another brand of RBC restoration

Outcomes

Restoration longevity

Notes

Results for marginal staining reported in Table 1 for only 43 of the 44 restorations evaluated. (1) "restoration experienced a bulk fracture and loss of restorative material substantial enough to expose the dentin. The loss of restorative material created a situation where it was not possible to rate this restoration for any of the other categories" (page 365). Additionally, half of the restorations in each group also received surface sealer postplacement and two subjects were not treated due to depth of caries (pulp exposures anticipated). It should also be noted that although the authors listed postoperative sensitivity among the criteria to be evaluated they did not mention how this would be measured and they did not include any data for this criteria or provide any information in the results nor discussion regarding postoperative sensitivity. Therefore, we included this study only in the longevity portion of this review

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"At the operative appointment, eligible participants were randomly assigned to 1 of 4 groups. While the operators were aware of this assignment, the evaluators and the participants were not. Thus the study design was a randomized, double‐blind clinical trial"

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants were blinded but operators were not

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"..the evaluators and the participants were not aware of the assignment"

Incomplete outcome data (attrition bias)
All outcomes

High risk

There is no mention of how missing data due to dropouts were treated

Selective reporting (reporting bias)

Low risk

All relevant outcomes reported

Other bias

Low risk

None detected

Burrow 2009

Methods

Trial design: Parallel‐group

Location: Dental school postgraduate clinic Bangkok, Thailand

Funding source: None mentioned

Participants

Inclusion criteria: At least 1 moderate to deep primary occlusal caries (at least 2 mm deep after caries removal) in a first or second permanent molar without caries on other surfaces; at least 1 opposing tooth; periodontal tissues healthy or mildly inflamed without gingival recession/alveolar bone loss; no previous signs and symptoms of pulpal and periapical disease, preoperative sensitivy relieved immediately after removal of stimulus, and no spontaneous pain; at least 1 antagonist tooth with occlusal contact more than 50% of the occlusal surface

Age: 18‐40 years

Exclusion criteria: Either the cavity depth after caries removal was less than 2 mm or a pulp exposure or near pulp exposure, in which a calcium hydroxide agent was placed; psychological disorders; neurological diseases; TMD; pregnancy or lactation; patients taking any analgesic or anti‐inflammatory drugs regularly; allergies to materials used in the trial; teeth with previous restoration(s), tooth surface loss (attrition, erosion, abrasion or abfraction); teeth diagnosed with cracked tooth syndrome; teeth that had received orthodontic treatment in past 3 months

Number of randomised individuals: 72

Number of randomised teeth: 106

Number of individuals evaluated: 70

Dropouts: 2

Interventions

RMGI liner under RBC restoration using 2 different bonding agents compared to no liner under RBC restoration using 2 different bonding agents

Outcomes

Postoperative hypersensitivity as measured CRM on a VAS, yes/no criteria, and also by patient reporting

Notes

Some participants had multiple restorations in different quadrants

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"...blocking randomization list"

Allocation concealment (selection bias)

Low risk

"...sealed envelope"

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants were blinded but operators were not

Blinding of outcome assessment (detection bias)
All outcomes

High risk

"One to four restorations were randomly allocated in each patient by a single operator (DB) according to a blocking randomization list." "At recall, the evaluator (DB) was blinded to the restoration that was being evaluated"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

"Two patients (three restorations) were lost during recall and were excluded before data analysis (from telephone interviewing, these patients reported no postoperative tooth sensitivity in daily function)"

Selective reporting (reporting bias)

Low risk

"…five patients (five restorations) missed the one‐week recall; however, these patients were still included in the data analysis. All patients attended the one‐month recall"

Other bias

Low risk

None detected

Efes 2006

Methods

Trial design: Split‐mouth

Location: Dental school faculty practice Istanbul, Turkey

Funding source: None mentioned

Participants

Inclusion criteria: Patients with 2 primary occlusal caries in molars in occlusion that were not mobile. Lesions diagnosed by visual inspection and radiographically

Age: 18 to 48 years

Exclusion criteria: Poor oral hygiene

Number of randomised individuals: 54

Number of randomised teeth: 27 in each group

Number of individuals evaluated: 50

Dropouts: 4

Interventions

Flowable liner under 2 brands RBC restoration compared to no liner under same 2 brands RBC restoration

Outcomes

Postoperative hypersensitivity as measured by patient reporting

Restoration longevity

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

"…materials were allocated randomly"

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No information provided

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

"The examiners were not involved in the filling placements"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All data reported

Selective reporting (reporting bias)

Low risk

All data reported

Other bias

Low risk

None detected

Strober 2013

Methods

Trial design: Parallel‐group

Location: Private dental offices, USA

Funding source: NIDCR

Participants

Inclusion criteria: Moderate to deep primary occlusal caries (at least 2 mm deep after caries removal) in a first or second permanent molar without caries on other surfaces; at least 1 opposing tooth; periodontal tissues healthy or mildly inflamed without gingival recession/alveolar bone loss; no previous signs and symptoms of pulpal and periapical disease, preoperative sensitivity relieved immediately after removal of stimulus, and no spontaneous pain; at least 1 antagonist tooth with occlusal contact more than 50% of the occlusal surface

Age: 15‐60 years

Exclusion criteria: Either the cavity depth after caries removal was less than 2 mm or a pulp exposure or near pulp exposure, in which a calcium hydroxide agent was placed; psychological disorders; neurological diseases; TMD; pregnancy or lactation; patients taking any analgesic or anti‐inflammatory drugs regularly; allergies to materials used in the trial; teeth with previous restoration(s), tooth surface loss (attrition, erosion, abrasion or abfraction); teeth diagnosed with cracked tooth syndrome; teeth that had received orthodontic treatment in past 3 months

Number of randomised individuals: 341

Number of randomised teeth: 347

Number of individuals evaluated: 333

Dropouts: 8

Interventions

RMGI liner under RBC restoration compared to no liner under RBC restoration

Outcomes

Postoperative hypersensitivity as measured by CRM on a VAS

Notes

Caries classification and dentin caries activity for each lesion, sleep bruxism and caries risk for each patient were also assessed

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"On enrolment, eligible participants were randomly assigned one to one (blocking within practice, using random block sizes) between the following treatment arms..."

Allocation concealment (selection bias)

Low risk

Randomization done centrally ‐ not in each practice

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Participants may or may not have been blinded – no information provided

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Operator and evaluator were the same person "P‐Is completed restorations according to the treatment arm assigned and liner (if used)" and "P‐Is saw participants for evaluation at one and four weeks after treatment"

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All data reported

Selective reporting (reporting bias)

Low risk

All data reported

Other bias

Low risk

None detected

Wegehaupt 2009

Methods

Trial design: Parallel‐group

Location: Göttingen, Germany

Funding source: University of Göttingen

Participants

Inclusion criteria: Caries media or caries profunda (according to bitewing radiographs), insufficient fillings, positive reaction to a vitality test (cold test), no signs of pulp inflammation, no spontaneous pain attacks before treatment, only premolars and molars, only 1 filling per tooth, and a minimum extension of the cavity of 1 mm in width

Age: 18 years or older

Exclusion criteria: Patients under 18 years, pregnancy, breastfeeding, immunosuppressed or addicted patients

Number of randomised individuals: 123

Number of randomised teeth: 123

Number of individuals evaluated: 123

Dropouts: None

Interventions

Calcium hydroxide (CaOH) liner under 2 brands RBC restoration compared to no liner under 2 brands RBC restoration

Outcomes

Postoperative hypersensitivity as measured by patient reporting

Notes

Maximum age of participants not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

"The decision to use a calcium hydroxide liner or not was made by tossing a coin"

Allocation concealment (selection bias)

Unclear risk

No information provided

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

Participants were blinded. "The patients were not told to which cavity‐depth group their tooth was allocated and if calcium hydroxide was used or not."  Operators were not blinded but risk of bias still low even though operator not blinded as it is not possible to blind the operator

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No information provided

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All data reported

Selective reporting (reporting bias)

Low risk

All data reported

Other bias

Low risk

None detected

CRM: cold response measurement; RBC: resin‐based composite; RMGI: resin‐modified glass ionomer; TMD: temporomandibular disorder; VAS: visual analog scale.

Characteristics of excluded studies [ordered by study ID]

Jump to:

Study

Reason for exclusion

Akpata 2006

Liners not studied

Andersson‐Wenckert 2002

Sandwich technique study

Andersson‐Wenckert 2004

Sandwich technique study

Ernst 2002

Interventions not randomized

Ernst 2003

Interventions not randomized

Fagundes 2009

Liners not studied

Grogono 1990

Sandwich technique study

Huth 2003

No control or comparison group

Kaurani 2007

Interventions not randomized

Knibbs 1992

Sandwich technique study

Loguercio 2001

Liners not studied

Noro 1983

Interventions not randomized, restorative material no longer available (UV light‐cured RBC)

Rasmusson 1998

Inappropriate study design ‐ the study compared 1 brand of RBC placed without a liner to a second brand of RBC placed with a flowable composite as a liner

Shi 2010

Liners not studied

Unemori 2001

Interventions not randomized

van Dijken 1999

Sandwich technique study

Vilkinis 2000

Sandwich technique study

Whitworth 2005

Inappropriate study design ‐ the decision of which restoration to place (composite or amalgam) was left to the discretion of the operator and information regarding the decisions was not provided

RBC: resin‐based composite; UV: ultra violet.

Data and analyses

Open in table viewer
Comparison 1. Liner versus no liner

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Postoperative hypersensitivity (POH) by patient report (Y/N) Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Liner versus no liner, Outcome 1 Postoperative hypersensitivity (POH) by patient report (Y/N).

Comparison 1 Liner versus no liner, Outcome 1 Postoperative hypersensitivity (POH) by patient report (Y/N).

1.1 24 hours follow‐up

1

88

Risk Ratio (M‐H, Random, 95% CI)

0.26 [0.11, 0.64]

1.2 1 week follow‐up

3

299

Risk Ratio (M‐H, Random, 95% CI)

0.56 [0.26, 1.17]

1.3 1 month follow‐up

3

253

Risk Ratio (M‐H, Random, 95% CI)

0.44 [0.15, 1.34]

2 Postoperative hypersensitivity (POH) by patient report (VAS) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.2

Comparison 1 Liner versus no liner, Outcome 2 Postoperative hypersensitivity (POH) by patient report (VAS).

Comparison 1 Liner versus no liner, Outcome 2 Postoperative hypersensitivity (POH) by patient report (VAS).

2.1 1 week follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 1 month follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 Cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

Analysis 1.3

Comparison 1 Liner versus no liner, Outcome 3 Cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation).

Comparison 1 Liner versus no liner, Outcome 3 Cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation).

3.1 24 hours follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 1 week follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 1 month follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 Cold response measurement (CRM) (VAS) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

Analysis 1.4

Comparison 1 Liner versus no liner, Outcome 4 Cold response measurement (CRM) (VAS).

Comparison 1 Liner versus no liner, Outcome 4 Cold response measurement (CRM) (VAS).

4.1 1 week follow‐up

2

447

Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.67, 0.26]

4.2 1 month follow‐up

2

444

Mean Difference (IV, Random, 95% CI)

‐0.33 [‐0.76, 0.11]

5 Cold response measurement (CRM) (Y/N) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Analysis 1.5

Comparison 1 Liner versus no liner, Outcome 5 Cold response measurement (CRM) (Y/N).

Comparison 1 Liner versus no liner, Outcome 5 Cold response measurement (CRM) (Y/N).

5.1 1 week follow‐up

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 1 month follow‐up

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6 Restoration failure at 1 year follow‐up Show forest plot

4

281

Risk Ratio (M‐H, Random, 95% CI)

1.0 [0.07, 15.00]

Analysis 1.6

Comparison 1 Liner versus no liner, Outcome 6 Restoration failure at 1 year follow‐up.

Comparison 1 Liner versus no liner, Outcome 6 Restoration failure at 1 year follow‐up.

Study flow diagram.
Figures and Tables -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Liner versus no liner, Outcome 1 Postoperative hypersensitivity (POH) by patient report (Y/N).
Figures and Tables -
Analysis 1.1

Comparison 1 Liner versus no liner, Outcome 1 Postoperative hypersensitivity (POH) by patient report (Y/N).

Comparison 1 Liner versus no liner, Outcome 2 Postoperative hypersensitivity (POH) by patient report (VAS).
Figures and Tables -
Analysis 1.2

Comparison 1 Liner versus no liner, Outcome 2 Postoperative hypersensitivity (POH) by patient report (VAS).

Comparison 1 Liner versus no liner, Outcome 3 Cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation).
Figures and Tables -
Analysis 1.3

Comparison 1 Liner versus no liner, Outcome 3 Cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation).

Comparison 1 Liner versus no liner, Outcome 4 Cold response measurement (CRM) (VAS).
Figures and Tables -
Analysis 1.4

Comparison 1 Liner versus no liner, Outcome 4 Cold response measurement (CRM) (VAS).

Comparison 1 Liner versus no liner, Outcome 5 Cold response measurement (CRM) (Y/N).
Figures and Tables -
Analysis 1.5

Comparison 1 Liner versus no liner, Outcome 5 Cold response measurement (CRM) (Y/N).

Comparison 1 Liner versus no liner, Outcome 6 Restoration failure at 1 year follow‐up.
Figures and Tables -
Analysis 1.6

Comparison 1 Liner versus no liner, Outcome 6 Restoration failure at 1 year follow‐up.

Liner versus no liner for Class I and Class II resin‐based composite restorations

Patient or population: Patients requiring Class I or Class II resin‐based composite restorations

Settings: General practice

Intervention: Liner

Comparison: No liner

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of restorations
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk*

Corresponding risk

No liner

Liner

Postoperative hypersensitivity (POH) (Patient‐reported Y/N)

Follow‐up: 1 week

100 per 1000

56 per 1000
(26 to 117)

RR 0.56
(0.26 to 1.17)

299
(3 studies)

⊕⊕⊝⊝1
low

POH was also measured at 24 hours (1 trial at high risk of bias) and 1 month (3 trials at high/unclear risk of bias). A benefit in favour of liners was shown at 24 hours; this difference was not maintained at any other time point

1 additional high risk of bias study measured patient‐reported POH using VAS. A benefit was shown in favour of liners at 1 week and 1 month follow‐up

Postoperative cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation)

Follow‐up: 1 week

The mean postoperative CRM at 1 week (time it took in seconds for patient to feel cold sensation) was 16 seconds

MD 6 seconds more
(1.36 more to 10.64 more)

88
(1 study)

⊕⊕⊝⊝2
low

CRM was also measured at 24 hours (1 trial at high risk of bias) and 1 month (1 trial at high risk of bias). No difference was shown between the use of liners and no liners at either time point

Other methods of measuring CRM (using VAS or Y/N response) showed no difference between liners and no liners at any time point

Restoration failure

Follow‐up: 1 year

7 per 1000

7 per 1000
(0 to 104)

RR 1.00
(0.07 to 15.00)

281
(4 studies)3

⊕⊕⊝⊝1
low

Restoration failure at 2‐year follow‐up also showed no difference between the use of liners or not

Adverse events

None reported

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval; MD: mean difference; RR: risk ratio; VAS: visual analog scale

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

*Assumed risk based on control group risk.
1Downgraded due to high risk of bias and imprecision.
2Downgraded due to single study at high risk of bias.
34 studies reported on restoration failure at 1 year. However, no failures were reported in either group for 3 of the 4 studies; these studies do not inform the RR presented.

Figures and Tables -
Comparison 1. Liner versus no liner

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Postoperative hypersensitivity (POH) by patient report (Y/N) Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 24 hours follow‐up

1

88

Risk Ratio (M‐H, Random, 95% CI)

0.26 [0.11, 0.64]

1.2 1 week follow‐up

3

299

Risk Ratio (M‐H, Random, 95% CI)

0.56 [0.26, 1.17]

1.3 1 month follow‐up

3

253

Risk Ratio (M‐H, Random, 95% CI)

0.44 [0.15, 1.34]

2 Postoperative hypersensitivity (POH) by patient report (VAS) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 1 week follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2.2 1 month follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 Cold response measurement (CRM) (time it took in seconds for patient to feel cold sensation) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

3.1 24 hours follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.2 1 week follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3.3 1 month follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

4 Cold response measurement (CRM) (VAS) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 1 week follow‐up

2

447

Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.67, 0.26]

4.2 1 month follow‐up

2

444

Mean Difference (IV, Random, 95% CI)

‐0.33 [‐0.76, 0.11]

5 Cold response measurement (CRM) (Y/N) Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

5.1 1 week follow‐up

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

5.2 1 month follow‐up

1

Risk Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

6 Restoration failure at 1 year follow‐up Show forest plot

4

281

Risk Ratio (M‐H, Random, 95% CI)

1.0 [0.07, 15.00]

Figures and Tables -
Comparison 1. Liner versus no liner