Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04679220
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2020-12-14
Brief Title:
36-Months Clinical Evaluation of Preheated and Room Temperature Resin Composite
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
36-Months Clinical Evaluation of Preheated Resin Composite
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 institutions 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 study28 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None