Investigation of the Effect of Deep Margin Elevation Technique on the Clinical Performance of Endocrown Restorations Produced by Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM) System

January 16, 2024 updated by: Onur Adson, Hacettepe University
The aim of this clinical study is to investigate the impact of the deep margin elevation technique on the clinical performance of CAD/CAM endocrown restorations in deep Class II cavities.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the impact of the deep margin elevation technique on the clinical performance of endocrown restorations made from nano-ceramic blocks produced using the CAD/CAM system for class II cavities with deep margins. Factors such as color harmony with adjacent teeth and restorations, discoloration, anatomical form continuity, adaptation, secondary caries, and retention will be examined in the nano-ceramic block material.

Various treatment options are available for the restoration of posterior group teeth. Factors such as restoration material, condition of supporting tooth tissue, patient habits, and clinical protocols affect the lifespan of restorations. Advances in tooth preparations ensure the preservation of sound tooth structure and the longevity of restorations.

The CAD/CAM system is a technology used in dentistry, consisting of three essential elements: data acquisition, design, and production. With this system, dentists can design and produce restorations such as veneers, crowns, and bridges using digital modeling and manufacturing methods.

The restoration of endodontically treated teeth may require different approaches than post-core and crown restorations that can affect mechanical resistance. The development of adhesive techniques and the importance of minimally invasive dentistry have led to new therapeutic approaches, such as monolithic endocrown restorations fixed to the pulp chamber and cavity margins.

Dental adhesion is the attractive force between the tooth surface and the applied material, and dentin bonding systems have been developed to ensure adhesion between the two structures. These systems enhance adhesion by increasing dentin surface energy and facilitating the spread of adhesive resin into the dentin.

Procedures such as isolation, measurement, cementation, and residual cement cleaning can be challenging in cases with deep margins. Clinical strategies can assist in overcoming isolation difficulties in subgingival margin areas where adhesive procedures are applied.

The restoration of teeth with advanced substance loss can be a challenging process for operators, and the selection of the correct treatment plan is crucial. This clinical research aims to examine the impact of the deep marginal elevation technique on the clinical performance of CAD/CAM-produced endocrown restorations.

Study Type

Interventional

Enrollment (Actual)

100

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
      • Ankara, Turkey, 06100
        • Hacettepe 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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy individuals without any uncontrolled systemic diseases.
  • Individuals aged between 18 and 65 years.
  • Individuals who pay attention to oral hygiene by brushing their teeth twice a day.
  • Patients with at least one canal-treated posterior tooth, multiple cusp loss, and at least one tooth wall loss identified during intraoral examination.
  • Patients who have successfully completed periodontal and endodontic treatments and do not exhibit any subjective symptoms.

Voluntary individuals who agree to participate in the study and sign the informed consent form will be included in the research.

Exclusion Criteria:

  • Individuals with uncontrolled systemic diseases.
  • Individuals with mental retardation who cannot establish cooperation.
  • Individuals with advanced periodontal disease.
  • Individuals using removable partial dentures.
  • Individuals with bruxism.
  • Individuals with malocclusion.
  • Patients with advanced substance loss requiring extraction of the relevant tooth, and individuals with deep margins requiring periodontal interventions.

Individuals who, after being informed about the study, choose not to read the informed consent form and decline to participate in the study.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Supragingival margins
Active Comparator: Subgingival margins (G-ænial Universal Injectable)

Matrix: Methacrylate monomer %31. Fillers: Silica, Barium Glass %69

G-ænial Universal injectable is a light-cured, radiopaque universal high-strength composite that can be used for all restorative indications while offering excellent viscosity and perfect direct syringe application. It has enhanced thixotropic properties that allow you to create the most beautiful & durable restorations with a minimum of manipulation.
Procedure: Deep Margin Elevation (G-ænial Universal Injectable)
Deep margin elevation (DME), or coronal margin relocation (CMR), is a procedure used to raise or reposition sub-gingival margins into supra-gingival margins using several materials to increase marginal integrity and bonding strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: From baseline to 24 month
Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorations materyal. Charlie: Any loss of restorative material
From baseline to 24 month
Marginal discoloration
Time Frame: From baseline to 24 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding Marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scorsese: Alfa: No discoloration. Bravo: Discoloration without. Charlie:Discoloration with penetration in pulpal direction
From baseline to 24 month
Marginal Adaptation
Time Frame: From baseline to 24 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
From baseline to 24 month
Seconder Caries
Time Frame: From baseline to 24 month
Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries presented. Charlie Caries present
From baseline to 24 month

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Şükran Bolay, Prof., Hacettepe University
  • Principal Investigator: Taha Yasin Sarıkaya, Hacettepe University
  • Principal Investigator: Onur Adson, Hacettepe 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

Helpful Links

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 25, 2022

Primary Completion (Actual)

June 25, 2023

Study Completion (Estimated)

April 25, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-22110

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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