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

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
Participants Number of participants randomised: 30 patients
Age: ≥ 20 years (mean = 45 years)
Sex: 12 males, 18 females
Inclusion criteria:
  • in good general health

  • had at least 20 teeth

  • had at least 1 pair of similarly sized non‐carious cervical lesions, without undercuts. The lesions were located in the same arch but on opposing sides

  • all teeth selected for the study had occlusal contacts, with no more than 50% of the cavo‐surface margin involving enamel

  • had been willing to sign the informed consent form before starting treatment


Exclusion criteria:
  • with extremely poor oral hygiene, criteria 2 and 3 of periodontitis, or with heavy bruxism habits

  • exhibited self‐reported spontaneous hypersensitivity


Number of participants evaluated: 30 patients
Withdrawals/loss to follow‐up: none
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 The gingival tissue of teeth was retracted with the retraction cord (Proretract, FGM Dent Prod Ltda)"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
Outcomes Outcomes:
  • patients' preferences (immediately after removal of each isolation method)

  • gingival tissue damage: the presence of gingival laceration (immediately after the restorative procedure and again after 1 week), the gingival condition including gingival insertion level and bleeding (after 1 week), gingival sensitivity (after 1 week)

  • clinical time required to perform each restoration

  • retention rates and performance of adhesive restorations at baseline and 6, 12, and 18 months after restoration: marginal staining, fractures/retention, marginal adaptation, postoperative sensitivity, and recurrent caries


Time points: immediately after restorative procedure, 1 week, 6, 12, and 18 months after the restoration.
Diagnostic criteria:
  • FDI World Dental Federation clinical criteria for the evaluation of direct and indirect restorations. (2 experienced examiners, blinded to the group assignment, performed the follow‐up examinations using a mirror and a double probe. Both examiners evaluated all the restorations once and independently. When disagreements occurred during the evaluations, they had to reach consensus. Before evaluation, the examiners were trained in the FDI criteria. They observed 10 photographs that were representative of each score for each criterion. After that and on 2 occasions, they evaluated 10‐15 teeth that were not included in the study sample. An intraexaminer and interexaminer agreement of at least 85% was necessary before we began the evaluation. The training was performed by 1 professor, a specialist in restorative dentistry with more than 15 years of clinical and research experience.) Retention of restorations was defined as no fractures/cracks; small hairline crack; or 2 or more or larger hairline cracks or chipping or both (not affecting the marginal integrity

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
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