NCT04679220

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

36-Months Clinical Evaluation of Preheated Resin Composite

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 20 Years – 30 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dental Leakage

Interventions

Type	Name	Description
PROCEDURE	Preheating	For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-06-01
• Completion: 2020-06-30
• First posted: 2020-12-22
• Last updated: 2020-12-22

Locations

1 site across 1 country: Egypt