Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838483
Status:
UNKNOWN
Last Update Posted:
2021-04-09
First Post:
2021-04-05
Brief Title:
Clinical Performance of Posterior Indirect Adhesive Restorations
Sponsor:
Okan University
Organization:
Okan University
Study Overview
Official Title:
Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
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:
Clinical performance of indirect adhesive restorations - onlays overlays- luted with light-cured composite resin will be evaluated
Detailed Description:
Indirect adhesive restorations are indicated in large Class II defects replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes but also have possibility of strengthening the remaining tooth structure Indirect technique decreases polymerization shrinkage reduces microleakage and also improves the marginal seal when comparing direct resin composites Furthermore it provides improved physical and mechanical properties ideal occlusal morphology more precise control of proximal contours and contacts Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement Updated approaches now include the use of composite resins as luting agent
This study will be carried out as a prospective study with assessment of the restorations after three years PASS 11 Software was used to calculate the sample size At least 77 indirect adhesive restorations will be included for this study Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study 83 indirect adhesive restorations in at least 60 patients will be included The patients who will not meet all the inclusion criteria will be excluded from the study A signed informed consent form will be obtained from all patients before beginning the study
Restorations will be evaluated clinically according to FDI World Dental Federation criteria Three main groups- esthetic functional biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5 Statistical analysis will be performed using R v353 Software and the SIGNtest function in the BSDA package p 005
This study will be carried out as a prospective study with assessment of the restorations after three years PASS 11 Software was used to calculate the sample size At least 77 indirect adhesive restorations will be included for this study Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study 83 indirect adhesive restorations in at least 60 patients will be included The patients who will not meet all the inclusion criteria will be excluded from the study A signed informed consent form will be obtained from all patients before beginning the study
Restorations will be evaluated clinically according to FDI World Dental Federation criteria Three main groups- esthetic functional biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5 Statistical analysis will be performed using R v353 Software and the SIGNtest function in the BSDA package p 005
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