Clinical Performance of Posterior Indirect Adhesive Restorations

Not Applicable

• Conditions: Dental Caries; Endodontically Treated Teeth; Dental Restoration Failure of Marginal Integrity; Wear, Occlusal
• Interventions: Device: Indirect adhesive restoration of posterior teeth

• Registration Number: NCT04838483
• Lead Sponsor: Okan University

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 (v.3.5.3) Software and the SIGN.test function in the BSDA package (p \<0.05).

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-07
• Last Update Submitted: 2021-04-07
• Study First Posted: 2021-04-09
• Last Update Posted: 2021-04-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indirect restorations luted with light-cured composite resin.	Indirect adhesive restoration of posterior teeth	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.

Primary Outcome Measures

Name	Time	Method
Survival rate	at 5 years	FDI World Dental Federation criteria functional properties

Secondary Outcome Measures

Name	Time	Method
Esthetic properties	at 5 years	FDI World Dental Federation criteria

Trial Locations

Locations (1)

Istanbul Okan University Faculty of Dentistry; 🇹🇷 Istanbul, Tuzla, Turkey