Clinical Evaluation of Posterior Indirect Adhesive Restorations

Study Overview
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Brief Summary
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Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.

Detailed Description
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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).

Official Title
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Clinical Performance of Indirect Adhesive Restorations Luted With Light-cured Composite Resin: A 3-year Study

Conditions
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Dental Caries, Endodontically Treated Teeth, Dental Restoration Failure of Marginal Integrity, Wear, Occlusal, Indirect Posterior Restoration

Intervention / Treatment
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* Device: Indirect adhesive restoration of posterior teeth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Significant loss of dental hard tissue Endodontically treated teeth in posterior region Replacement of large compromised existing restoration Large Class II restoration Age of 18-60 years Good oral hygiene Presence of interproximal contact to at least one neighboring teeth In occlusion with antagonist teeth Cavity preparation with at least one cuspal coverage Exclusion Criteria: Serious medical problems or allergies to substances and/or products to be used Severe periodontal problems Poor oral hygiene Direct pulp capping Presence of parafunctional behaviors Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A Prospective Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indirect restorations luted with light-cured composite resin.<br>Subjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician. Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation. | Device: Indirect adhesive restoration of posterior teeth<br>* Indirect restoration of significant loss of dental hard tissue<br>* Other names: Ceramic onlay or overlay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FDI World Dental Federation criteria | Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations. Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view. Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health. | at 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indirect restoration, Adhesive restoration, Cementation, Composite resin