Dental Caries Clinical Trial
Official title:
Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin: A 3-year Study
Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.
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 and radiographically according to FDI World Dental
Federation criteria over 3-year period. 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 (v.3.5.3) Software and
the SIGN.test function in the BSDA package (p <0.05).
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