Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04679220 |
Other study ID # |
36.MCEPRCRCL |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2017 |
Est. completion date |
June 30, 2020 |
Study information
Verified date |
December 2020 |
Source |
Mansoura University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.