Clinical trial NCT06543680: Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems
Official title: Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems: Two Years Randomized Clinical Study in Class ᴠ
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Secondary Caries Dental Restoration Failure of Marginal Integrity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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: 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

Eligibility 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.

Primary outcomes:
measure: Percentage of aesthetic, functional and biological properties for each group
timeFrame: 2 years after restoration
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry mansoura university
state: Dakahliya
Study officials:
affiliation: Faculty of Dentistry, Mansoura University, Egypt
name: Mohamed E Hamouda, Assistant Lecturer
role: PRINCIPAL_INVESTIGATOR
References: