Loguercio 2015.
Study characteristics | ||
Methods | Design: split‐mouth RCT Recruitment period: April to October 2010 Administration setting: clinic of the School of Dentistry at the State University of Ponta Grossa (Paraná, Brazil) Country: Brazil Funding source: National Council for Scientific and Technological Development (CNPq), restorative products supported by SDI Brazil |
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Participants | Number of participants randomised: 30 patients Age: ≥ 20 years (mean = 45 years) Sex: 12 males, 18 females Inclusion criteria:
Exclusion criteria:
Number of participants evaluated: 30 patients Withdrawals/loss to follow‐up: none |
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Interventions | Total number of groups: 2 Intervention: rubber dam: "the rubber dam was inserted (Madeitex, São José dos Campos, Brazil) along with the rubber dam retainer No. 212 (KG Sorensen, Barueri, Brazil)" Control: cotton rolls/retraction cord: "a mouth retractor (Arc‐Flex, FGM Dent Prod Ltda, Joinville, Brazil) was applied, and cotton rolls and saliva ejectors were used to keep the operative field dry. The gingival tissue of teeth was retracted with the retraction cord (Proretract, FGM Dent Prod Ltda)" Restorative treatment: adhesive restorations of NCCLs |
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Outcomes | Outcomes:
Time points: immediately after restorative procedure, 1 week, 6, 12, and 18 months after the restoration. Diagnostic criteria:
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Notes | Adverse events: not reported This article was published in November to December 2015 but failed to be retrieved in previous searches up to August 2016. The reason may be the delay in articles being uploaded to electronic databases, and the journal was not included in handsearching |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "In each subject, the choice of each isolation method was randomly determined by tossing a coin before the restorative intervention in order to guarantee concealment of the allocation" Comment: method stated and appropriate, low risk of bias |
Allocation concealment (selection bias) | Low risk | Allocation concealment was conducted by tossing a coin before the restorative intervention Comment: low risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The patient and the operator were not blinded to the procedure, but the examiner was" Comment: high risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The patient and the operator were not blinded to the procedure, but the examiner was" Comment: the examiners were blinded, low risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up Comment: low risk of bias |
Selective reporting (reporting bias) | Low risk | The stated objectives and methods of the study appeared to match the listed outcomes Comment: low risk of bias. |
Other bias | Low risk | No contamination and carry‐across effect was detected Comment: low risk of bias |