Comparison of the Clinical Performance of High Strength Hybrid Ceramic Indirect Restorations Cemented on Endodontically Treated Teeth Using Bioactive Versus Conventional Self Adhesive Resin Cements.

June 8, 2025 updated by: Ahmed Nabil Hassan Shalaby, Cairo University

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Overlays on Endodontically Treated Molars Using Bioactive Versus Conventional Self-Adhesive Resin Cement: Two-Year Randomized Clinical Trial

Cementation of indirect restoration is a determinant of the success or failure of the fabricated restoration and consequentially the entire tooth. While there are numerous commercially available resin cements in the dental market, not all have been sufficiently assessed with significant follow up periods to clinically determine their success or failure. As such, this research will be conducted to elucidate if there is a viability to the cementation of indirect hybrid ceramic blocks over endodontically treated teeth using bioactive self-adhesive resin cement and determining whether it provides a clinical advantage and improved restoration serviceability in the oral cavity.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

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

No

Description

Inclusion Criteria:

  • Patient Related Criteria:
  • Adult patients (age: 21-50 years) of both genders.
  • Able to tolerate necessary restorative procedures.
  • Willing to sign the informed consent.
  • Accepts the follow-up period.

Tooth Related Criteria:

  • Endodontically treated first and second permanent molars.
  • Access cavities with one missing proximal wall i.e. Occluso-mesial/distal cavities
  • Patients with proper oral hygiene

Exclusion Criteria:

  • Endodontically treated anterior, premolar and third molar teeth
  • Badly broken-down teeth
  • Hopelessly carious/destructed teeth necessitating extraction
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Cervical carious lesions
  • Medically compromised patients
  • Patients with known allergies to Latex and/or resinous material

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Indirect Restorations cemented using Coltene Solocem Resin Cement
Other: Resin Cement
Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.
Other: Resin Cement
Self adhesive resin cement
Active Comparator: Indirect Restorations cemented using SHOFU BeautiLink Resin Cement
Other: Resin Cement
Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.
Other: Resin Cement
Self adhesive resin cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified USPHS Criteria
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Cairo 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 (Estimated)

June 23, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 8, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANCU-8-1-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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