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

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
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
Interventions Study has 9 arms:
  • Group 1: ART approach in class I caries lesion + H‐GIC (Fuji IX)

  • Group 2: ART approach in class I caries lesion + H‐GIC (Ketac‐Molar)

  • Group 3: ART approach in class II caries lesion + H‐GIC (Fuji IX)

  • Group 4: ART approach in class II caries lesion + H‐GIC (Ketac‐Molar)

  • Group 5: CT in class I caries lesion + H‐GIC (Fuji IX)

  • Group 6: CT in class I caries lesion + H‐GIC (Ketac‐Molar)

  • Group 7: CT in class II caries lesion + H‐GIC (Fuji IX)

  • Group 8: CT in class II caries lesion + H‐GIC (Ketac‐Molar)

  • Group 9: CT in class I caries lesion + amalgam


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
  • Cumulative success rate assessed by ART criteria at 6, 12 and 24 months. Scores 2, 3, 4 and 5 were considered as failure (2 = restoration present, defect at margin and/or surface wear of 0.5 to 1.0 mm; 3 = present, gross defect at margin and/or surface wear of > 1.0 mm; 4 = not present, restoration has disappeared; 5 = not present, because other treatment has been performed.

  • Recurrent caries was determined through cavitation and softened dentin at the margin of the restoration.

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 
 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