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.

NCT ID: NCT06787469

Last Updated: 2025-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Endodontically Treated Molar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be conducted on the form of a randomized controlled, unicenter, clustered two-arm superiority trial with a 1:1 allocation.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indirect Restorations cemented using Coltene Solocem Resin Cement

Group Type ACTIVE_COMPARATOR

Resin Cement

Intervention Type OTHER

Self adhesive resin cement

Indirect Restorations cemented using SHOFU BeautiLink Resin Cement

Group Type ACTIVE_COMPARATOR

Resin Cement

Intervention Type OTHER

Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.

Interventions

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Resin Cement

Bioactive self adhesive resin cement (SHOFU BeautiLink) used to cement indirect restorations to endodontically treated molars.

Intervention Type OTHER

Resin Cement

Self adhesive resin cement

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Nabil Hassan Shalaby

Assistant Lecturer - Conservative Dentistry Department - MIU

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed N Shalaby, Masters Restorative Dentistry

Role: CONTACT

+201014850792

Other Identifiers

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ANCU-8-1-2025

Identifier Type: -

Identifier Source: org_study_id

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