Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental restoration.
- Who it may be relevant to
- Registry conditions: Secondary Caries Dental Restoration Failure of Marginal Integrity. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems: Two Years Randomized Clinical Study in Class ᴠ
Overview
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
Interventions
- Other Dental restoration
Each patient will randomly receive one cervical restoration with one of the tested restorative systems
Primary outcome measures
- Percentage of aesthetic, functional and biological properties for each group [Time frame: 2 years after restoration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of dentistry mansoura university — Al Mansurah
Identifiers
NCT: NCT06543680 · A0103023CD