Yu 2004.
Methods |
Design: cluster split‐mouth RCT Number of participants: 60 Setting: school dental clinic Country: China Unit of randomisation: tooth Unit of analysis: tooth pairs Follow‐up: 6, 12 and 24 months Dropout: 33.3% and 55% after 12 and 24 months |
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Participants |
Number randomised (participants): 60 children/167 teeth (72 ART group and 95 CT group)
Number analysed: 27 child/69 teeth
Age mean and SD (range): 7.4 SD 1.24 (7‐9 years)
Gender: female 33 (55%), male 27 (45%) Average dmft score: not reported Dentition: primary Type of caries lesion: simple and multiple surface caries lesion Inclusion criteria: healthy children with ≥ 1 pair of primary molars with caries lesions of similar size and class Exclusion criteria: not reported |
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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. |
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Outcomes |
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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 |
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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 All outcomes | High risk | Comments: blinding not possible ‐ operator knew the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The assessment were recorded by a researcher who did not performed any treatment" |
Incomplete outcome data (attrition bias) All outcomes | 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