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

Mansoura University

Status: Enrolling

Conditions: Secondary Caries Dental Restoration Failure of Marginal Integrity

Treatments: Other: Dental restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT06543680

A0103023CD

Details and patient eligibility

About

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

Full description

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

Enrollment: 35 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 3 patient groups, including a placebo group

Resin Modified Glass Ionomer cement

Active Comparator group

Description:

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

Treatment:

Other: Dental restoration

Self-Adhesive flowable composite

Placebo Comparator group

Description:

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

Treatment:

Other: Dental restoration

Self-Adhesive composite hybrid

Placebo Comparator group

Description:

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

Treatment:

Other: Dental restoration