36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite

Dental Leakage Clinical Trial

Official title: 36-Months Clinical Evaluation of Preheated Resin Composite

Status Completed

Clinical Trial Summary

Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.

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 split mouth design. Thirty-five 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 70 Class I 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 October 2017 to June 2020 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% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 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 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects. ;

Related Conditions & MeSH terms

• Dental Leakage

• NCT number: NCT04679220
• Study type: Interventional
• Source: Mansoura University
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Completion date: June 30, 2020