Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)

December 3, 2023 updated by: Mansoura University

Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations

The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Faculty of dentistry , Mansoura university

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Good general health
  • Good oral hygiene
  • Patient aging 20-40 y
  • Patients with proximal deep carious lesion
  • International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
  • Normal response to a vitality test.

Exclusion Criteria:

  • poor general health
  • poor oral hygiene
  • Teeth would need direct pulp capping
  • Teeth act as abutment for fixed or removable prosthesis.
  • patients with excessive parafunctional habits
  • Patient potentially unable to be compliant to recall visits

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Highly viscous Glass Ionomer
Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Procedure: Highly viscous glass ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Experimental: Low shrinkage Flowable Composite
Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Procedure: Low shrinkage Flowable Composite (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Experimental: Resin Modified Glass Ionomer
Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Procedure: Resin Modified Glass Ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Experimental: Bioactive Ionic Resin
Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Procedure: Bioactive Ionic Resin (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingiva
Time Frame: three year follow up
Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva
three year follow up
Modified World Dental Federation (FDI) clinical Criteria
Time Frame: three year follow up

  1. Functional Properties of restorations:

    1. Fracture of material and retention
    2. Marginal adaptation
    3. Radiographic examination

  2. Biological Properties of restorations

    1. Postoperative (hyper-sensitivity and tooth vitality
    2. Recurrence of caries
    3. Tooth integrity (enamel cracks, tooth fractures)
    4. Periodontal Response
    5. Adjacent mucosa

Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor.

Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated
three year follow up

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

August 24, 2021

Primary Completion (Actual)

January 5, 2022

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9153193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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