Clinical Evaluation of Posterior Indirect Adhesive Restorations

March 3, 2020 updated by: Gulsah YENIER, Okan University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Anticipated)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Tuzla
      • Istanbul, Tuzla, Turkey, 34959
        • Recruiting
        • Istanbul Okan University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Indirect restorations luted with light-cured composite resin.

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
Indirect restoration of significant loss of dental hard tissue
Other Names:
  • Ceramic onlay or overlay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FDI World Dental Federation criteria
Time Frame: at 3 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2019

Primary Completion (ANTICIPATED)

June 8, 2020

Study Completion (ANTICIPATED)

July 8, 2020

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (ACTUAL)

March 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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