Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04926883
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2021-06-03
Brief Title:
Comparison Between Sonic Fill and X-tra Fill in Clinical Performance
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Clinical Performance of Sonic-Activated High Viscosity Bulk-Fill Resin Composite in Comparison to Conventional Bulk-Fill Resin Composite Restorations in Posterior Teeth A Randomized Controlled Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
NOT_YET_RECRUITING
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:
The present study aims to evaluate a 2-years clinical performance of sonic-activated bulk-fill resin composite material sonic fill in comparison to conventional bulk-fill resin composite X-tra fill as posterior restorations The null hypothesis is that sonic-activated bulk-fill resin composite restoration shows no difference when compared to conventional bulk-fill resin composite in clinical performance over 2-years evaluations based on clinical assessment
Detailed Description:
Restorations will be evaluated 1 week after placement Baseline - T0 3 months T1 6 months T2 1-year T3 and 2-years T4 of clinical service by blinded calibrated examiner using modified United States Public Health Service USPHS criteria where score A Alpha stands for the clinically ideal restoration Score B Bravo is a clinically acceptable situation except for secondary caries Score C Charlie indicates clinically unacceptable restorations that must be replaced
The restorations will also be evaluated using revised FDI criteria with five grades for each criterion scores 1 to 3 indicated clinically acceptable restorations and scores 4 and 5 summarized clinically unacceptable situations indicating repair score 4 or replacement score 5
The restorations will also be evaluated using revised FDI criteria with five grades for each criterion scores 1 to 3 indicated clinically acceptable restorations and scores 4 and 5 summarized clinically unacceptable situations indicating repair score 4 or replacement score 5
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