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. 2017 Dec 28;2017(12):CD008072. doi: 10.1002/14651858.CD008072.pub2

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
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
Interventions Two treatment arms:
  • Group 1: ART approach + H‐GIC

  • Group 2: CT + composite with anaesthesia


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
  • Acceptability evaluated by Face Image Scale (5 pictures representing feelings ranging from very unhappy to very happy) before and after the procedure

  • Pain assessed by asking if the child felt any pain during the treatment and were willing to received the same treatment again

  • Success rate evaluated by USPH modified criteria after 6 months

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 
 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