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. 2021 May 17;2021(5):CD009858. doi: 10.1002/14651858.CD009858.pub3

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
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):
  • with NCCLs in mandibular premolars

  • in dentine but without pulp exposure

  • lesions above the gingival margins

  • teeth with NCCLs having no occlusal trauma

  • teeth with NCCLs having vital pulps


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
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
Outcomes Outcomes (as translated):
  • failure rate


Time points: 6 months
after restorative treatment
Diagnostic criteria:
  • failure criteria (as translated): restorations found not to exist was regarded as failure. No further detail was provided

Notes Adverse events: not stated
Sample size calculation: no details reported
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.