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

NCT06222918 | Unknown

• 1 other identifier: KA-22110
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

CAD/CAM; Endocrown; Deep Margin Elevation; İndirect

Outcome Measures

Primary Outcomes (4)

• Retention

  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

  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

  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

  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

Study Arms (2)

Supragingival margins

NO INTERVENTION

Subgingival margins (G-ænial Universal Injectable)

ACTIVE COMPARATOR

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)

Interventions

Deep Margin Elevation (G-ænial Universal Injectable) PROCEDURE

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

Subgingival margins (G-ænial Universal Injectable)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

• Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.

  PMID: 20305873 BACKGROUND

• Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15.

  PMID: 29153552 BACKGROUND

Related Links

• Related İnfo

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Şükran Bolay, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Taha Yasin Sarıkaya

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Onur Adson

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: December 25, 2022
• Primary Completion: June 25, 2023
• Study Completion: April 25, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

TU (1)