Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems

NCT ID: NCT06543680

Last Updated: 2024-08-09

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

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-29

Study Completion Date

2025-05-31

Brief Summary

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To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions

Detailed Description

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The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of 35 patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on 105 Class V restorations.A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.

No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from may 2023 to may 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.

Clinical evaluation for all restorations will be done at baseline (after insertion) and after 6, 12 and 24 months of clinical service by two calibrated independent examiners that will not share in restorations placement. It will be designed depending on modified USPHS criteria and FDI criteria

Conditions

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Secondary Caries Dental Restoration Failure of Marginal Integrity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Resin Modified Glass Ionomer cement

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type ACTIVE_COMPARATOR

Dental restoration

Intervention Type OTHER

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Self-Adhesive flowable composite

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type PLACEBO_COMPARATOR

Dental restoration

Intervention Type OTHER

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Self-Adhesive composite hybrid

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Group Type PLACEBO_COMPARATOR

Dental restoration

Intervention Type OTHER

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Interventions

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Dental restoration

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* Inclusion criteria will be fair oral hygiene patients with 30-60 years. Patients with at least three similarly sized non-carious cervical lesions (NCCLs) in vital teeth that need for restoration and depth of NCCLs will be 1-3 mm with at least 50% of margins without enamel.

Exclusion Criteria:

* Exclusion criteria will be patients with severe periodontitis, mobile teeth, fractures, severe bruxism, carious teeth, poor oral hygiene, teeth with irreversible pulpitis and endodontically treated teeth.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elbahloul

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed E Hamouda, Assistant Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Mansoura University, Egypt

Locations

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Faculty of dentistry mansoura university

Al Mansurah, Dakahliya, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed E Hamouda, Assistant Lecturer

Role: CONTACT

01018357630

Abeer E Elembaby, Professor

Role: CONTACT

01000033812

Other Identifiers

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A0103023CD

Identifier Type: -

Identifier Source: org_study_id

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