Luz 2012.
Methods |
Design: Parallel RCT Number of participant: 30 Setting: school of dentistry Country: Brazil Unit of randomisation: child Unit of analysis: child Follow‐up: 6 month Dropout: 23.3% after 6 months |
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Participants |
Number randomised (participants): 30 children (16 ART group and 14 CT group)
Number analysed: 23 children
Age mean and SD (range): 4‐7 years
Gender: Female 16 (53.3%), male 14 (46.7%) Average DMFT score: not reported Dentition: primary Type of caries lesion: approximal caries lesion Inclusion criteria: children who had at least one approximal active caries lesion in a primary molar and that was accessible to hand instruments. Exclusion criteria: children with spontaneous pain |
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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. |
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Outcomes |
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Notes | Funding not stated Trial register number not reported Sample size not calculated Intraexaminer reproducibility high ‐ kappa > 0.8 |
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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 All outcomes | High risk | Comments: blinding not possible ‐ operator knew the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comments: not reported |
Incomplete outcome data (attrition bias) All outcomes | 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 |