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Clinical Trial Summary

This study was designed to evaluate and compare the 2-year clinical performance of resin composite restorations in class II cavities with deep sub-gingival margins relocated using three different glass ionomer based restorative materials and flowable composite, based on FDI criteria.


Clinical Trial Description

The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the parallel design. One hundred and twenty adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 120 Class II restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from January 2020 to January 2022 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% success rate at 2 years) of posterior class II restorations restored with open sandwich and deep margin elevation techniques observed in previous studies. According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 120 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 120 subjects. ;


Study Design


Related Conditions & MeSH terms

  • Dental Restoration Failure of Marginal Integrity

NCT number NCT05125900
Study type Interventional
Source Mansoura University
Contact
Status Active, not recruiting
Phase N/A
Start date January 1, 2020
Completion date January 1, 2022

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