Ma 2012.
Study characteristics | ||
Methods | Design: parallel‐group RCT Recruitment period: 2009 to 2011 Administration setting: dental clinical of hospital Country: China Funding source: not stated |
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Participants | Number of participants randomised: 162; 162 teeth (rubber dam: 81; cotton rolls: 81) Randomisation unit: participant/tooth Age: not stated Sex: not stated Inclusion criteria (as translated):
Exclusion criteria: not stated Number of participants evaluated: 162; 162 teeth (rubber dam: 81; cotton rolls: 81) Withdrawals/loss to follow‐up: no losses to follow‐up |
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Interventions | Number of groups: 2 Intervention: rubber dam (as translated): "isolated with rubber dam (Optra Dam, Ivoclar Vivadent, 0.22 ~ 0.27 mm)" Control: cotton rolls (as translated): "isolated with cotton rolls placed in buccal and lingual vestibule" Restorative treatment: composite restorations of NCCLs |
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Outcomes | Outcomes (as translated):
Time points: 6 months after restorative treatment Diagnostic criteria:
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Notes | Adverse events: not stated Sample size calculation: no details reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (as translated): "One hundred and sixty‐two patients with non‐carious cervical lesions were stratified randomly distributed into two groups (n = 81) from June 2009 to June 2011" Comment: method of sequence generation not stated. Insufficient information reported to make a judgement |
Allocation concealment (selection bias) | Unclear risk | Not stated Comment: insufficient information reported to make a judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: operators and participants could not be blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated Comment: insufficient information reported to make a judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up |
Selective reporting (reporting bias) | Low risk | Comment: outcomes reported as planned |
Other bias | Unclear risk | Comment: no data on group comparability provided |
ART: atraumatic restorative treatment; IS: Isolite system; NCCLs: non‐carious cervical lesions; RCT: randomised controlled trial; RD: rubber dam.