无创伤修复治疗与常规修复治疗龋齿的比较
Referencias
References to studies included in this review
References to studies excluded from this review
References to ongoing studies
Additional references
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Methods | Design: cluster, parallel RCT (a child is a cluster) Number of participants: 75 Setting: nursing home Unit of randomisation: participant Dropout: 14.9 % after 6 months | |
| Participants | Number randomised: 75 participants; 174 teeth (73 ART group and 101 CT group) Average DMFT score: not reported Dentition: permanent Type of caries lesion: root caries | |
| Interventions | Two treatment arms:
ART was performed using only manual instrumentation to remove decayed tissue. Cotton rolls and a retraction cord were used to obtain relative isolation of the operative field. 2% chlorhexidine (Clorhexol 0.2 g/100 mL; Farpag®, Bogota, Colombia) was applied for 1 min and the cavity was dried and sealed with aglass ionomer cement modified with light‐curing composite resin (Vitremer™®, 3M ESPE, Seefeld, Germany). Interproximal metal and paper strips were used. Conventional technique was performed using a high‐speed handpiece with irrigation and round diamond burs of different diameters. Cavities were restored with RM‐GIC. Use of anaesthesia was not reported in any group. The interventions were conducted by 2 dentists. | |
| Outcomes |
| |
| Notes | Funding: COLCIENCIAS for the Young Researcher Scholarship‐Internship Program Trial register number not reported Sample size calculated Intraexaminer and interexaminer reproducibility not assessed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A series of random numbers was used to fabricate sealed envelopes that were only opened for the random allocation of the participants to each working group (ART or conventional technique with rotary instruments)" |
| Allocation concealment (selection bias) | Low risk | Quote: "A series of random numbers was used to fabricate sealed envelopes that were only opened for the random allocation of the participants to each working group (ART or conventional technique with rotary instruments)" |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comment: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comment: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "After six months, the condition of the restorations was assessed by two different prosthodontists, without awareness of the technique that was performed in each participant" |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "After six months, 64 participants were evaluated (32 men and 32 women) and 26 restorations (14.9%) were lost. Seven participants changed geriatric institutions and were lost to follow‐up, two died, and the two remaining participants were unreachable at the institution during the time of revision” |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes listed in the methods sections were included. |
| Other bias | High risk | Comment: no information provided about baseline characteristics of included participants. The analysis did not consider the pair data. |
| Methods | Design: cluster, parallel RCT (a child is a cluster) Number of participants: 107 Setting: dental school/hospital Unit of randomisation: participant Dropout: 15.8% and 33.6% after 12 and 24 months, respectively | |
| Participants | Number randomised: 107 (53 ART group and 54 CT group); 99 received the intervention/306 teeth (142 ART and 158 CT) Average DMFT score: 25.74 SD = 6.3 ART/28.54 SD = 5.0 CT Dentition: permanent Type of caries lesion: coronal or root caries | |
| Interventions | Two treatment arms:
The ART approach consisted of opening of the cavity with a dental enamel hatchet when necessary, removal of soft, completely demineralised carious tissue with excavators, conditioning of the cavity with polyacrylic acid for 20 s, washing and drying with cotton pellets and restoration with a high‐strength glass ionomer cement (GC Fuji IX). The CT procedure consisted of local anaesthesia, use of rotary instruments for access, rotary and hand instruments for removal of all carious tissue, conditioning of the cavity with a polyacrylic acid for 20 seconds, washing and drying with cotton pellets and a resin‐modified glass ionomer (GC Fuji II LC) to restore it. The interventions were conducted by 2 dentists | |
| Outcomes |
| |
| Notes | Funding: Irish Health Research Board Trial register number not reported Sample size calculated Interexaminer reproducibility high (kappa = 0.88) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomisation list, provided by a statistician involved in the study" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "The allocation sequence was concealed from the primary researcher treating the participants in sequentially numbered, opaque, sealed envelopes" Comment: unclear if the primary researcher is the same person who performed all restorations |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comment: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comment: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "Restorations were assessed after 6 months and after a year by a calibrated examiner who was not involved in the placement of restorations, and did not know which treatment had been provided for each case" |
| Incomplete outcome data (attrition bias) | High risk | Comment: loss to follow‐up 33.6% at 24 months |
| Selective reporting (reporting bias) | Unclear risk | Comment: restorations are not reported individually so we do not know how they compared to the overall average. It may have been space limits rather than deliberate selective reporting that is responsible for this. |
| Other bias | High risk | Comment: imbalance in DMFT score between groups |
| Methods | Design: parallel RCT Number of participants: 40 Setting: dental clinic Dropout: none | |
| Participants | Number randomised (participants): 40 (20 ART group and 20 CT group) Gender: female 19 (47.5%) and male 21 (52.5%) Average DMFT score: not reported Dentition: primary Type of caries lesion: occlusal caries | |
| Interventions | Two treatment arms:
ART group was treated using hand instruments only. The restorative material used was the H‐GIC, Fuji IX (GC®, Japan). Conventional restorative treatment was performed under local anaesthesia and rubber dam protection using rotary equipment. Cavity cleaning was restricted to removing all carious tissues in enamel and dentine using the drill. The restorative material used was the H‐GIC, Fuji IX (GC®, Japan) The interventions were conducted by 1 dentist | |
| Outcomes |
| |
| Notes | Funding: Brazilian Dental Association Trial register number not reported Sample size not calculated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The children were randomly allocated to a test and control group using a series of computer generated random numbers" |
| Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comment: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comment: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comment: not reported |
| Incomplete outcome data (attrition bias) | Low risk | Comment: no dropouts. All participants assessed |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes listed in the methods sections included |
| Other bias | Unclear risk | Comment: no information provided about baseline characteristics of included participants |
| Methods | Design: cluster, split‐mouth RCT Number of participant: 160 Setting: dental clinic Dropout: 22.5%, 29.4% and 64.4% after 6, 12 and 24 months, respectively | |
| Participants | Number randomised (participants): 160 children (96 ART group and 64 CT group)/325 teeth (162 ART and 163 conventional) Average DMFT score: 6.9 SD = 2.5 Dentition: primary Type of caries lesion: multiple surface caries lesion | |
| Interventions | Two treatment arms:
The ART procedure consisted of widening the opening in small cavities and removing thin enamel in larger cavity openings with a dental hatchet, until the enamel was free of visible demineralisation. Soft infected dentin was excavated from the cavity walls and floor with spoon excavators. No local anaesthesia was administered. Cavities were restored with composite (Pertac II) The CT procedure consisted of removing carious tissues using a micromotor and a handpiece with diamond and steel burs. The cavity was prepared following the minimal intervention concept. The interventions were conducted by 3 dentists. | |
| Outcomes |
| |
| Notes | Funding: WHO Collaborating Centre of the Radboud University Medical Centre in Nijmegen, The Netherlands, Hu‐Friedy, Germany, and 3M ESPE, Germany Trial register number not reported Sample size not calculated Interexaminer reproducibility moderate (kappa = 0.41) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The cavitied dentin lesions were randomly assigned to the treatment group after stratification for gender, operator, upper/lower jaw, and when needed according to left/right side of the mouth using a validated computer software program (trial Balance)" |
| Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comment: participants aware of different treatments |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comment: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "Two calibrated independent examiners who were blinded to the treatment method provided evaluated the occlusal and approximal parts of the restorations after 6 months, 1 year and 2 years..." |
| Incomplete outcome data (attrition bias) | High risk | Quote: "Ten children with 33 restorations were not evaluated at any evaluation time" "The total number of children evaluated after 0.5, 1 and 2 years was 124, 113 and 57, respectively" Comment: loss to follow‐up high at 2 years (64.4%) |
| Selective reporting (reporting bias) | Unclear risk | Comment: some results were reported in another study. Maybe there are other results not reported. |
| Other bias | Low risk | Comment: split‐mouth design with the same baseline diagnosis of the teeth within a tooth pair. |
| Methods | Design: cluster, parallel RCT Number of participants: 1629 children Setting: community setting Dropout: 15.6% and 51.47% after 12 and 24 months, respectively | |
| Participants | Number randomised (participants): 1629 children (868 ART group and 761 CT group)/ 6773 teeth (4976 ART and 1797 conventional) Average DMFT score: not reported Dentition: permanent Type of caries lesion: not reported
Exclusion criteria
| |
| Interventions | The study has 3 arms:
The ART procedure consisted of a manual excavation of dental caries and restoration with glass ionomer. CT with amalgam. No more details Use of anaesthesia was not reported in any group. The interventions were conducted by dentists and dental hygienists. | |
| Outcomes |
| |
| Notes | Funding: Inter‐American Development Bank Trial register number not reported Sample size calculated Results at 3 years not reported Interexaminer reproducibility > 0.75 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "In order to ensure balanced treatment groups within the schools, children were randomised in blocks of 4 or 10 depending on the size of the school. Schools with 15 children or fewer and, whenever possible, within a reasonable distance from one another were collapsed. The randomisation was accomplished using a computer‐based (SAS) block randomisation using random number seeds from a random digit table" |
| Allocation concealment (selection bias) | Low risk | Quote: "Assignment for all three countries was done in Washington, DC to ensure consistency" |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Unclear risk | Quote: "the PRAT project required its restoration evaluators to be trained and calibrated according to strict standard criteria so that their assessments were reliable and comparable" "At the end of the third year, an external international evaluator will conduct a final evaluation of the condition of restorations performed during the course of the project" Comment: not clear whether the assessments at 1 and 2 years were made by an operator who was not involved in the treatment phase |
| Incomplete outcome data (attrition bias) | High risk | Comment: loss to follow‐up high at 2 years (51.47%) |
| Selective reporting (reporting bias) | High risk | Comment: results at 3 years not reported |
| Other bias | High risk | Comment: DMF scores not reported. Information about supply of water fluoridation between countries not provided. The analysis did not consider the intracluster correlation coefficient. |
| Methods | Design: cluster, parallel RCT (a child is a cluster) Number of participants: 58 Setting: not reported Dropout: none | |
| Participants | Number randomised (participants): 58 (30 ART group and 28 CT group)/248 teeth (138 ART group and 110 CT group) Number analysed: 58 children/248 teeth Average DMFT score: not reported Dentition: primary Type of caries lesion: not reported Inclusion criteria: primary teeth with carious lesion of enamel or dentin | |
| Interventions | Two treatment arms:
The ART procedure consisted of opening the cavity using enamel hatchet and sharp excavators to remove the caries. Caries was removed from the dentino‐enamel junction using sharp spoon excavators of appropriate size before proceeding on to the floor of the cavity. The glass ionomer silver reinforced restorative was placed in the cavity. In CT caries was removed from the dentino‐enamel junction using high‐speed turbine before proceeding on to the floor of the cavity. The surfaces were then washed with water‐moistened cotton pellets and then blotted dry with fresh cotton pellets. The glass ionomer silver reinforced restorative were placed in the cavity. Use of anaesthesia was not reported in any group. The interventions were conducted by a dentist. | |
| Outcomes | Success rate was assessed as:
| |
| Notes | Funding not stated Trial register number not reported Sample size not calculated Intraexaminer reproducibility not assessed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The children were randomly divided into two groups" Comments: method not described. |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used. |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention. |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comments: not reported |
| Incomplete outcome data (attrition bias) | Low risk | Comments: no dropouts. All participants were assessed. |
| Selective reporting (reporting bias) | Low risk | Comments: results of all outcomes reported |
| Other bias | High risk | Comments: baseline characteristics and details about co‐interventions were not reported. Analysis did not consider the intracluster correlation coefficient. |
| Methods | Design: split‐mouth RCT Number of participants: 106 Setting: hospital Dropout: none | |
| Participants | Number randomised (participants): 106 participants/212 teeth (106 ART group and 106 CT group) Gender: 53 male (50%) and 53 female (50%) Average DMFT score: not reported Dentition: primary Type of caries lesion: not reported
Exclusion criteria:
| |
| Interventions | Two treatment arms:
For ART group the cavities were filled with FX glass ionomer cement (Japan Co., Ltd), after removing carious tooth tissues and undermined enamel with a sharp excavator. In CT the cavities were filled with silver amalgam (China Iron & Steel Research Institute Group), after removing carious tooth tissues and preparation of cavities with high‐speed turbine drill. Use of anaesthesia was not reported in any group. All interventions were conducted by the same dentist | |
| Outcomes |
| |
| Notes | Funding not stated Trial register number not reported Samples size not calculated Intraexaminer reproducibility not assessed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Self‐control method and randomised method were used to allocate teeth into two groups” Comments: method not described |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: participant aware of different treatments |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | High risk | Quote: “all the treatments and clinical examinations were done by the same operator” |
| Incomplete outcome data (attrition bias) | Low risk | Comments: all participants were assessed |
| Selective reporting (reporting bias) | Unclear risk | Comments: some outcomes were not reported in the methods section but were shown in the results. |
| Other bias | High risk | Comments: analysis did not consider the paired data |
| Methods | Design: cluster, parallel RCT (an individual is a cluster) Number of participant: 103 Setting: nursing homes Dropout: 25.2% after 12 months | |
| Participants | Number randomised (participants): 103 participants/162 teeth (78 ART group and 84 CT group) Number analysed: 77 participants/122 teeth Average DMFT score: 1.0 Dentition: permanent Type of caries lesion: root caries Inclusion criteria: > 60 years of age, having basic self‐care ability, and with root caries lesions ≥ 1 mm in depth Exclusion criteria: lesions involving or judged to be very close to the dental pulp | |
| Interventions | Two treatment arms:
The ART technique consisted of removing all the soft dentin only with hand instruments. Cotton rolls and gingival retraction cord were used when necessary for field isolation and moisture control. Cavity was conditioned for 10‐15 s. The prepared cavity was restored with a high‐strength chemically cured glass‐ionomer material (Ketac Molar, 3M ESPE, Seefeld, Germany). A clear cellulose matrix was used to build up the contour of the root. CT used local anaesthesia when required. Cotton rolls and gingival retraction cord were used for field isolation and moisture control. Decayed tooth tissues were removed by means of dental burs until the floor and walls of the cavity were found to be hard. The prepared cavity was conditioned with polyacrylic acid for 10‐15 seconds, washed, dried, and restored with a resin modified glass‐ionomer material (Fuji II LC, GC Corporation, Tokyo, Japan) The interventions were conducted by 1 dentist. | |
| Outcomes |
| |
| Notes | Funding: Hong Kong Research Grants Council (Ref. HKU 7244/02M) Trial register number: not reported Sample size calculated Intraexaminer reproducibility evaluated but not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "We tossed a coin to allocate the selected lesions randomly to receive one of the two study treatments" "For patients who had 2 root‐caries lesions, both types of treatment were provided" "The treatment assignment procedure was repeated if there were more than 2 lesions in a subject" |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "Restorations was assessed at six‐month intervals by a dentist who was not involved in the provision of the treatments, and who did not know which technique had been used in placing the restoration” “Blindness was possible because tooth‐colored glass‐ionomer material was used in both techniques, and the restorations had similar appearances." |
| Incomplete outcome data (attrition bias) | High risk | Quote: "The reasons for dropout were that the patients had died, were too ill to be examined, or were not at the home on the examination day" Comments: while the causes of dropout are indicated, the loss was high (25%) |
| Selective reporting (reporting bias) | Low risk | Comments: all outcomes listed in the methods sections were included. |
| Other bias | High risk | Comments: the analysis did not consider the paired data. |
| Methods | Design: Parallel RCT Number of participant: 30 Setting: school of dentistry Dropout: 23.3% after 6 months | |
| Participants | Number randomised (participants): 30 children (16 ART group and 14 CT group) Average DMFT score: not reported Dentition: primary Type of caries lesion: approximal caries lesion | |
| Interventions | Two treatment arms:
Children in the ART Group were treated according to ART approach using only hand instruments, no anaesthesia and restorative material was glass ionomer (Ketak‐Molar 3‐M ESPE, St. Paul, Minnesota). Only the demineralised carious tissue and unsupported enamel were removed. Matrix band and wooden wedges were used. Children in CT group were treated with local anaesthesia, rubber dam, rotary instruments and the cavity was filled with composite resin ( Z 350 3‐M ESPE, St. Paul, Minnesota). Only the demineralised carious tissue and unsupported enamel were removed. Matrix band and wooden wedges were used. The interventions were conducted by 1 dentist. | |
| Outcomes |
| |
| Notes | Funding not stated Trial register number not reported Sample size not calculated Intraexaminer reproducibility high ‐ kappa > 0.8 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of the treatment group after stratification for tooth in the upper/lower jaw using a ballot box" |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Unclear risk | Comments: not reported |
| Incomplete outcome data (attrition bias) | Low risk | Comments: for the outcomes evaluated, all participants were assessed |
| Selective reporting (reporting bias) | Low risk | Comments: all prespecified (primary and secondary) outcomes reported |
| Other bias | Unclear risk | Comments: baseline characteristics and details about co‐interventions not reported |
| Methods | Design: split‐mouth RCT Number of participant: 80 Setting: dental clinic Dropout: 3.75% after 6 months and 12.5% after 12 months | |
| Participants | Number randomised (participants): 80 children/160 teeth (80 ART group and 80 CT group) Average DMFT score: not reported Dentition: primary Type of caries lesion: single and multiple surface caries lesion
Exclusion criteria
| |
| Interventions | Two treatment arms:
Teeth in the ART group were treated with hand instruments only. The restorative material was glass ionomer (Ketak‐Molar 3‐M ESPE). In CT group, cavities were filled with silver amalgam (SDI), after removing carious tooth tissues and preparation of cavities with high and low‐speed drill. Both treatments were started without use of anaesthesia. The interventions were conducted by 1 dentist | |
| Outcomes |
| |
| Notes | Funding not stated Trial register number no reported Sample size calculated Intraexaminer reproducibility not assessed | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "We used a simple randomised to two treatment cited by Pocock (1993) and a table of random numbers, randomised formed by digits from 0 to 9 in a sequence from right to left and from top to bottom" |
| Allocation concealment (selection bias) | Low risk | Quote: "The concealment was performed through sealed envelopes numbered 1‐100, containing inside cards with corresponding number and an indication of the first treatment, obtained by the method mentioned, being sequentially archived. The listing and envelopes were made by a professional different to the researcher." |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: participant aware of different treatments |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "The restorations were evaluated by paediatric dentist who did not perform any treatment" |
| Incomplete outcome data (attrition bias) | Low risk | Comments: low dropout rate (12.5%), reasons for missing outcome data unlikely to be related to true outcome |
| Selective reporting (reporting bias) | Low risk | Comments: all prespecified (primary and secondary) outcomes reported |
| Other bias | Low risk | Comments: split‐mouth design with the same baseline diagnosis of the teeth within a tooth pair |
| Methods | Design: parallel RCT Number of participants: 217 Setting: not reported Dropout: 10.1% and 11.1% after 7 and 12 months, respectively | |
| Participants | Number randomised (participants): 217 participants in 3 arms (77 ART group, 72 CT group and 68 CarisolvTM group) Average DMFT score: not reported Dentition: primary Type of caries lesion: multiple‐surface caries lesion | |
| Interventions | Three treatment arms:
With the ART approach, only hatchets and excavators were used. The CT group was treated by excavation with a stainless steel bur without water cooling (speed: ± 750 rpm). For CarisolvTM group, excavation was performed with special hand instruments after the application of the gel. In all groups a matrix band and wooden wedges were inserted after cleaning the cavity. Cotton wool rolls were used to isolate the cavity so as to prevent contamination with saliva and/or blood. The smear layer was removed from the dentine by conditioning for 15 seconds and rinsed and dried with respectively 3 wet and 3 dry cotton pellets. Hand‐mix GIC (Fuji IX) was placed into the cavity, using the finger press method; Vaseline was applied to the index finger and pressed on for 3 seconds, the finger being removed sideways. No local anaesthesia was used in any group. Interventions were conducted by 4 dentists. | |
| Outcomes |
| |
| Notes | Funding: GC Europe provided the GIC; Medi Team provided Carisolv and blunt instruments Trial register number not reported Sample size not calculated Interexaminer reproducibility ranged between 0.66 and 0.84 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “217 children were randomly divided into three groups for treatment with one of three different methods” Comments: insufficient information about the sequence generation process |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Unclear risk | Quote: “The restorations were evaluated after 7 months (first evaluation) and one year (second evaluation) by 4 final‐year students from The Netherlands” Comments: unclear if different from who was involved in placing them. Blinding would have been possible given that all restorations were GIC. |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "There were 193 children present at the second evaluation (t=2), 149 of them could participate in the scoring for success or failure of the restorations." Comments: loss to follow‐up was low at 1 year (12%). Reasons for missing outcomes were not reported. |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
| Other bias | Unclear risk | Comments: baseline characteristics and details about co‐interventions not reported |
| Methods | Design: parallel RCT Number of participants: 403 Setting: not reported Dropout: none | |
| Participants | Number randomised (participants): 403 children (202 ART group and 201 CT group) Dentition: primary Type of caries lesion: multiple surface caries lesion Average DMFT score: not reported | |
| Interventions | Two treatment arms:
In ART group, only hand instruments were used, i.e. hatchets and excavators. In CT group, excavation of the demineralised tooth material was carried out by means of stainless steel round burs in a handpiece (750 rpm), without water cooling. In both groups, only the demineralised carious tooth tissue and unsupported enamel were removed. After cleaning the cavity, a matrix band and wooden wedges were applied. Cotton wool rolls were used to isolate the cleaned cavity from contamination with saliva and/or blood. After conditioning the dentin for 15 s, hand‐mix H‐GIC (Chemflex, Dentsply/deTrey) was placed into the cavity in both groups. No local anaesthesia was used in either group. Interventions were conducted by 4 dentists and 1 dental student. | |
| Outcomes |
| |
| Notes | Funding: this study was supported by Dentsply/deTrey (UK), ESPE, Dental Union and WOTRO (the Netherlands) Trial register number not reported Sample size not calculated Interexaminer reproducibility was good (kappa = 0.87). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Treatments were allocated randomly" Comments: how this was done not described |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Unclear risk | Quote: “the Venham score was observed by one of the authors, not participating in the treatments, though aware of the treatment method that was randomly chosen for the child” Comments: this could bias the results, favouring one of the treatment methods. |
| Incomplete outcome data (attrition bias) | Low risk | Comments: for the outcomes evaluated all participants were assessed. |
| Selective reporting (reporting bias) | Unclear risk | Comments: all outcomes listed in the methods sections were included, but the results were described incompletely. |
| Other bias | Low risk | Comments: the study appears to be free of other sources of bias. No relations could be found between the treatment and either gender or operator in a number of participants. |
| Methods | Design: cluster, parallel RCT Number of participant: 299 Setting: not reported Dropout: 51.7% after 30 months | |
| Participants | Number randomised (participants): 299 children (153 ART group and 146 CT group)/408 teeth (205 ART and 203 CT) Average dmft score: not reported Dentition: primary Type of caries lesion: multiple surface caries lesion Inclusion criteria: schoolchildren in good mental and physical health with ≥ 1 small proximally situated cavity in a primary molar that was accessible to hand instruments from the occlusal surface and where no pulp exposure was expected. The measurements of the cavity had to be < 1 mm mesio‐distally and 2 mm in bucco‐lingual/palatinal direction. The antagonist tooth had to be present. | |
| Interventions | The study had four arms:
Children in the ART approach were treated using only hand instruments (i.e. hatchets and spoon excavators) to remove the caries lesions. Participants in the CT group were treated with rotary instruments, i.e. stainless steel round burs in a slow handpiece without water cooling. After access to the cavity was obtained, at first the enamel‐dentine border was cleaned and after that the remaining caries was removed. In both treatments after finishing the preparation a piece of metal matrix band (Matricodent) was applied and fixed with a wooden wedge. In all cases hand‐mixed glass ionomer (Fuji IX, GC Corporation) was used as restoration material. The interventions were conducted by one dentist, one dental student and two hygienists. | |
| Outcomes |
| |
| Notes | Funding: Foundation of Youth Dental Care in Paramaribo, Suriname and GC company provided the GIC Trial register number not reported Samples size not calculated Intraexaminer consistency values range from 0.73‐0.84 (Cohen’s kappa) Interexaminer consistency was calculated: 0.72 for the 6‐month evaluation and 0.93 for the evaluation after 30 months. Some of the children received a second restoration placed in another molar. In these cases the same treatment protocol for both restorations was used. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The children were randomly divided into four treatment groups" "The randomization list was obtained by means of SPSS" |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "The restorations were evaluated by two final‐year dental students of ACTA (who did not perform any treatment)" |
| Incomplete outcome data (attrition bias) | High risk | Quote: "The majority of the dropouts concerned absent patients and shed teeth" Comments: loss to follow‐up close to 50% at 30 months. How many losses due to absence or shedding not reported |
| Selective reporting (reporting bias) | High risk | Comments: discomfort was not reported at all measured times, only during deep excavation and restoration. Not was included a mean of all measured. |
| Other bias | High risk | Comments: baseline characteristics or details about co‐interventions not reported. The analysis did not consider the intra‐cluster correlation coefficient. |
| Methods | Design: parallel RCT Number of participants: 393 Setting: school Dropout: 41.7% after 36 months | |
| Participants | Number randomised (participants): 393 children Number analysed: 229 children (116 ART group and 113 CT group) Average dmft score: not reported Dentition: primary Type of caries lesion: multiple surface caries lesion
Exclusion criteria: not reported | |
| Interventions | Two treatment arms:
The ART group used hand instruments to remove caries lesion and the cavities were restored with H‐GIC (Chem‐Flex Dentsply/DeTrey). In the CT group, cavities were excavated using a round, stainless steel drill (750 rpm) and restored with H‐GIC (Chem Flex Dentsply/DeTrey). Use of anaesthesia was not reported in any group. Interventions conducted by 2 dentists and 2 dental students | |
| Outcomes | Succes rate assessed by WHO criteria after 1.5, 6, 12 , 24 and 36 months. Success includes the following scores: 00 and 10. Scores of 11, 12, 13, 20, 21, 30 and 40 are regarded as failures. The scores 50, 60, 70 and 90 are not related to success or failure. | |
| Notes | Funding: The Foundation Backer Dirks Fund provided a grant and Dentsply/DeTrey suggested the material available Trial register number not reported Sample size not calculated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “There were 393 children selected for the study. These were randomly divided into 2 groups and randomly assigned to the four practitioners” Commnents: insufficient information about the sequence generation process |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "The evaluators were blinded of the method of treatment (ART or conventional)" |
| Incomplete outcome data (attrition bias) | High risk | Comments: loss to follow‐up was high at 3 years (41.7%). Reasons for missing outcomes were not reported. |
| Selective reporting (reporting bias) | High risk | Comments: all outcomes listed in the methods sections were included, but the results were described incompletely. Results before 3 years were not reported. |
| Other bias | Unclear risk | Comments: baseline characteristics and details of co‐interventions not reported |
| Methods | Design: cluster split‐mouth RCT Number of participants: 60 Setting: school dental clinic Dropout: 33.3% and 55% after 12 and 24 months | |
| Participants | Number randomised (participants): 60 children/167 teeth (72 ART group and 95 CT group) Average dmft score: not reported Dentition: primary Type of caries lesion: simple and multiple surface caries lesion | |
| Interventions | Study has 9 arms:
The ART cavity preparation method followed the directions given in the ART technique manual, ensuring removal of all softened carious dentin at the dentinoenamel junction. Strong, unsupported enamel cusps were left intact where access for caries removal was deemed satisfactory. Bases were not used with any of the restorations. The cavities for CT were prepared with conventional rotatory instruments. The cavities were not used with any of the restorations. The GICs were coated with a varnish after placement, and the amalgam restorations were left unpolished. No local anaesthesia was used in either group. The interventions were conducted by 2 dentists. | |
| Outcomes |
| |
| Notes | Funding: supply of commercial materials and some financial assistance was provided by ESPE Dental Medizin GmbH and by GC International Corp Trial register number not reported Sample size not calculated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Treatments were assigned randomly to one of nine groups” Comments: how this was done is not described. |
| Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
| Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: participants aware of different treatments |
| Blinding of participants and personnel (performance bias) ‐ operator | High risk | Comments: blinding not possible ‐ operator knew the intervention |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "The assessment were recorded by a researcher who did not performed any treatment" |
| Incomplete outcome data (attrition bias) | High risk | Comments: loss to follow‐up was high at 2 years (55%). |
| Selective reporting (reporting bias) | Low risk | Comments: all prespecified outcomes reported |
| Other bias | High risk | Comments: the analysis did not consider the paired data. |
ART: atraumatic restorative treatment; CPI: Community Periodontal Index; CT: conventional treatment; dmft: decayed, missing and filled primary teeth); DMFT: decayed, missing and filled permanent teeth; GIC: glass ionomer cement; H‐GIC: high‐viscosity glass ionomer cement; RCT: randomised controlled trial; RM‐GIC: resin‐modified glass‐ionomer cement; USPHS: US Public Health Service
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Compares ART with chemomechanical caries removal (Papacarie) | |
| Compares ART with chemomechanical caries removal (Carisolv) | |
| Compares ART with chemomechanical caries removal (Carisolv) | |
| ART technique was modified with Papacarie | |
| Not an RCT | |
| Not an RCT. Only the schools that received experimental group were randomised. CT group was not randomised. | |
| Not an RCT. One village received ART, a second village was treated with amalgam and a third village was the control. | |
| Not an RCT. The electricity failed on a number of days and the principal investigator decided that all children, who had been bussed to the WHO Centre for treatment, would be treated using the ART approach. | |
| Not RCT | |
| Not RCT | |
| Compares ART with different GICs | |
| Does not compare ART with conventional treatment | |
| Not an RCT | |
| No randomisation between CT and ART, only between materials used for ART | |
| Modified ART, using hand instruments and a caries‐removal solution (Caridex) | |
| Does not compare ART with CT. Compares different materials | |
| Does not compare ART with CT. Compares two types of GICs | |
| Not an RCT | |
| Compares ART with chemomechanical caries removal (Papacarie) | |
| Modified ART. Not an RCT | |
| Does not compare ART with conventional treatment. Compares different GICs | |
| Not an RCT | |
| Not an RCT. One village received ART and those in the other village received CT | |
| Modified ART; this involved accessing caries using high speed to break enamel | |
| Not an RCT. Two operators did not strictly follow the randomisation procedure for the selection of the treatment technique. | |
| Not an RCT. The electricity failed on a number of days and the principal investigator decided that all children, who had been bussed to the WHO Centre for treatment, would be treated using the ART approach. | |
| Not an RCT |
ART: atraumatic restorative treatment; CT: conventional treatment; GIC: glass ionomer cement; RCT: randomised controlled trial
Characteristics of ongoing studies [ordered by study ID]
| Trial name or title | Comparison of efficacy and acceptability of caries removal methods ‐ a randomized controlled clinical trial |
| Methods | Design: RCT Country: India |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | The study has three arms
|
| Outcomes | Primary outcomes
Secondary outcomes
|
| Starting date | December 2015 |
| Contact information | DR SS Hiremath, [email protected] |
| Notes |
| Trial name or title | Cost‐efficacy between ART and composite resin restorations in primary molars |
| Methods | Design: parallel RCT, single‐blind Country: Brazil |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | Two treatment arms:
|
| Outcomes | Primary outcome
Secondary outcome
|
| Starting date | October 2015 |
| Contact information | Daniela P Raggio, PhD |
| Notes |
| Trial name or title | Effectiveness of ART and conventional treatment ‐ practice‐based clinical trial |
| Methods | Design: parallel RCT, single blind Country: Brazil |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | Two treatment arms:
|
| Outcomes | Primary outcome
Secondary outcome
|
| Starting date | January 2016 |
| Contact information | Professor Daniela P Raggio |
| Notes |
| Trial name or title | Evaluation of atraumatic restorative treatment (ART) in the family health strategy of Teresina, Piauí |
| Methods | Design: parallel RCT, double blind Country: Brazil |
| Participants | Inclusion criteria
Exclusion criteria
|
| Interventions | Two treatment arms: Group 1: ART using H‐GIC |
| Outcomes | Primary outcome
Secondary outcome
|
| Starting date | September 2015 |
| Contact information | Marcoeli Silva De Moura. Universidade Federal Do Piauí. marcoeli‐[email protected] |
| Notes | Funding: Fundação de Amparo a Pesquisa do Estado do Piauí ‐ FAPEPI |
ART: atraumatic restorative treatment; CT: conventional treatment; GIC: glass ionomer cement; H‐GIC: high‐viscosity glass ionomer cement; RCT: randomised controlled trial; RM‐GIC: resin‐modified glass‐ionomer cement
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Restoration failure ‐ primary teeth ‐ longest follow‐up Show forest plot | 5 | Odds Ratio (Random, 95% CI) | 1.60 [1.13, 2.27] | |
| Analysis 1.1  Comparison 1 Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, Outcome 1 Restoration failure ‐ primary teeth ‐ longest follow‐up. | ||||
| 1.1 Single and multiple cavity surfaces | 1 | Odds Ratio (Random, 95% CI) | 2.75 [0.50, 15.16] | |
| 1.2 Multiple cavity surfaces | 3 | Odds Ratio (Random, 95% CI) | 1.62 [1.03, 2.55] | |
| 1.3 Type of cavity surfaces not reported | 1 | Odds Ratio (Random, 95% CI) | 0.79 [0.12, 5.45] | |
| 2 Pain ‐ primary teeth Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | ‐0.65 [‐1.38, 0.07] |
| Analysis 1.2  Comparison 1 Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, Outcome 2 Pain ‐ primary teeth. | ||||
| 3 Participant experience ‐ discomfort Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Analysis 1.3  Comparison 1 Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, Outcome 3 Participant experience ‐ discomfort. | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Restoration failure ‐ primary teeth ‐ longest follow‐up Show forest plot | 1 | Odds Ratio (Random, 95% CI) | Totals not selected | |
| Analysis 2.1  Comparison 2 Atraumatic restorative treatment using composite versus conventional treatment using composite, Outcome 1 Restoration failure ‐ primary teeth ‐ longest follow‐up. | ||||
| 2 Participant experience ‐ dental anxiety Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 2.2  Comparison 2 Atraumatic restorative treatment using composite versus conventional treatment using composite, Outcome 2 Participant experience ‐ dental anxiety. | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Restoration failure ‐ permanent teeth ‐ longest follow‐up Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| Analysis 3.1  Comparison 3 Atraumatic restorative treatment using resin‐modified glass ionomer cement (RM‐GIC) versus conventional treatment using RM‐GIC, Outcome 1 Restoration failure ‐ permanent teeth ‐ longest follow‐up. | ||||
| 2 Secondary caries Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| Analysis 3.2  Comparison 3 Atraumatic restorative treatment using resin‐modified glass ionomer cement (RM‐GIC) versus conventional treatment using RM‐GIC, Outcome 2 Secondary caries. | ||||
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Forest plot of comparison 1. Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, outcome: 1.1 restoration failure (primary teeth) ‐ longest follow‐up
Comparison 1 Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, Outcome 1 Restoration failure ‐ primary teeth ‐ longest follow‐up.
Comparison 1 Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, Outcome 2 Pain ‐ primary teeth.
Comparison 1 Atraumatic restorative treatment using high‐viscosity glass ionomer cement (H‐GIC) versus conventional treatment using H‐GIC, Outcome 3 Participant experience ‐ discomfort.
Comparison 2 Atraumatic restorative treatment using composite versus conventional treatment using composite, Outcome 1 Restoration failure ‐ primary teeth ‐ longest follow‐up.
Comparison 2 Atraumatic restorative treatment using composite versus conventional treatment using composite, Outcome 2 Participant experience ‐ dental anxiety.
Comparison 3 Atraumatic restorative treatment using resin‐modified glass ionomer cement (RM‐GIC) versus conventional treatment using RM‐GIC, Outcome 1 Restoration failure ‐ permanent teeth ‐ longest follow‐up.
Comparison 3 Atraumatic restorative treatment using resin‐modified glass ionomer cement (RM‐GIC) versus conventional treatment using RM‐GIC, Outcome 2 Secondary caries.
| Atraumatic restorative treatment (ART) using high‐viscosity glass ionomer cement (H‐GIC) compared with conventional restorative treatment using H‐GIC for dental caries | |||||
| Patient or population: people with dental caries Settings: community settings and dental clinics Intervention: ART using H‐GIC Comparison: conventional treatment using H‐GIC | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | |
| Assumed risk | Corresponding risk | ||||
| Conventional treatment with H‐GIC | ART with H‐GIC | ||||
| Restoration failure (primary dentition) at 12 to 24 months | 471 per 1000 | 588 per 1000 | OR 1.60 | 643 participants/846 teeth | ⊕⊕⊝⊝ |
| Pain | Mean pain (primary teeth) was 1.38 (SD 1.21) | Mean pain (primary teeth) was 0.73 (SD 1.14) | MD 0.65 lower (1.38 lower to 0.07 higher) | 40 participants | ⊕⊕⊝⊝ |
| Adverse events | ‐ | ‐ | ‐ | ‐ | Not measured |
| *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% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence | |||||
| 1We downgraded the evidence by two levels because of very serious concerns regarding risk of bias: we judged all five studies as high risk of performance bias, three studies as high risk of attrition bias, and two studies as high risk of reporting bias. | |||||
| Atraumatic restorative treatment (ART) using composite resins compared with conventional restorative treatment using composite resins for dental caries | |||||
| Patient or population: people with dental caries Settings: community settings and dental clinics Intervention: ART using composite Comparison: conventional treatment using composite | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Quality of the evidence | |
| Assumed risk | Corresponding risk | ||||
| Conventional treatment | ART | ||||
| Restoration failure (primary dentition) | 362 per 1000 | 387 per 1000 | OR 1.11 | 57 participants/100 teeth | ⊕⊝⊝⊝ |
| Pain | ‐ | ‐ | ‐ | ‐ | Not measured |
| Adverse events | ‐ | ‐ | ‐ | ‐ | Not measured |
| *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% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence | |||||
| 1We downgraded the evidence by three levels: one level because it is a single study (indirectness) and two levels because of very serious concern regarding the risk of bias (high risk of performance bias and high risk of attrition bias). The result was also very imprecise. | |||||
| Atraumatic restorative treatment (ART) using resin‐modified glass ionomer cement (RM‐GIC) compared with conventional restorative treatment using RM‐GIC for dental caries | |||||
| Patient or population: people with dental caries Settings: community settings and dental clinics Intervention: ART using RM‐GIC Comparison: conventional treatment using RM‐GIC | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Quality of the evidence | |
| Assumed risk | Corresponding risk | ||||
| Conventional treatment | ART | ||||
| Restoration failure (primary dentition) | ‐ | ‐ | ‐ | 0 studies | No studies included |
| Restoration failure (permanent teeth) | 75 per 1000 | 180 per 1000 | OR 2.71 | 64 participants/141 teeth | ⊕⊝⊝⊝ |
| Pain | ‐ | ‐ | ‐ | ‐ | Not measured |
| Adverse events | ‐ | ‐ | ‐ | ‐ | Not measured |
| *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% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence | |||||
| 1We downgraded the evidence by one level because it is a single study (indirectness), one level because of concern regarding high risk of performance bias, and one level because the result was imprecise. | |||||
| ART with one material versus conventional treatment with another material | |||
| ART material | Conventional treatment material | Outcomes | Effect estimate OR (95% CI) |
| H‐GIC | Amalgam | Restoration failure ‐primary teeth – 2 studies (Miranda 2005; Yu 2004). Studies reporting on single + multiple lesions | 2.15 (0.73 to 6.35); I2 = 0% |
| Pain (primary dentition) – 1 study (Miranda 2005). Studies reporting on single + multiple lesions | 1.44 (0.45 to 4.60) | ||
| GIC | Amalgam | Restoration failure ‐ primary teeth – 1 study (Ling 2003). Studies reporting on lesion type: not reported | 0.78 (0.30 to 2.02) |
| Restoration failure ‐ permanent, immature teeth – 1 study (Estupiñan‐Day 2006). Studies reporting on lesion type: not reported | 1.71 (1.32 to 2.22) | ||
| Pain ‐ permanent, immature teeth (Estupiñan‐Day 2006) | 0.41 (0.35 to 0.47) | ||
| H‐GIC | Composite and local anaesthetic | Restoration failure ‐ primary teeth – 1 study (Luz 2012). Studies reporting on multiple lesions | 8.00 (1.24 to 51.48) |
| Pain (primary dentition) – 1 study (Luz 2012) | 2.22 (0.51 to 9.61) | ||
| H‐GIC | RM‐GIC and local anaesthetic | Restoration failure ‐ permanent, mature teeth – 2 studies (Da Mata 2015; Lo 2006). Studies reporting on coronal/root caries | 1.46 (0.74 to 2.88); I2 = 0% |
| CI: confidence interval; OR: odds ratio | |||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Restoration failure ‐ primary teeth ‐ longest follow‐up Show forest plot | 5 | Odds Ratio (Random, 95% CI) | 1.60 [1.13, 2.27] | |
| 1.1 Single and multiple cavity surfaces | 1 | Odds Ratio (Random, 95% CI) | 2.75 [0.50, 15.16] | |
| 1.2 Multiple cavity surfaces | 3 | Odds Ratio (Random, 95% CI) | 1.62 [1.03, 2.55] | |
| 1.3 Type of cavity surfaces not reported | 1 | Odds Ratio (Random, 95% CI) | 0.79 [0.12, 5.45] | |
| 2 Pain ‐ primary teeth Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | ‐0.65 [‐1.38, 0.07] |
| 3 Participant experience ‐ discomfort Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Restoration failure ‐ primary teeth ‐ longest follow‐up Show forest plot | 1 | Odds Ratio (Random, 95% CI) | Totals not selected | |
| 2 Participant experience ‐ dental anxiety Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Restoration failure ‐ permanent teeth ‐ longest follow‐up Show forest plot | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
| 2 Secondary caries Show forest plot | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
