Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696431
Status:
RECRUITING
Last Update Posted:
2023-01-25
First Post:
2023-01-07
Brief Title:
Clinical Performance of Three Universal Adhesives in Posterior Restorations
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations
Status:
RECRUITING
Status Verified Date:
2022-11
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:
This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations based on International dental federation FDI criteria
Detailed Description:
The description of the experimental design will follow the Consolidated Standards of Reporting Trials CONSORT statement The present study will be a double blinded patients and examiner randomized clinical trial anticipating the split-mouth design 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations
No advertisement will be made for participant recruitment forming a sample of convenience Each patient will sign a consent form before participating in the current study The study will be conducted from November 2022 to November 2024 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 a previous study with a similar study design Parameters including a significance level of 5 p 005 and a power of 80 were used to calculate an appropriate sample size of 28 cases Allowing for a 20 drop-out rate the total sample size was set at 30 cases
No advertisement will be made for participant recruitment forming a sample of convenience Each patient will sign a consent form before participating in the current study The study will be conducted from November 2022 to November 2024 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 a previous study with a similar study design Parameters including a significance level of 5 p 005 and a power of 80 were used to calculate an appropriate sample size of 28 cases Allowing for a 20 drop-out rate the total sample size was set at 30 cases
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