Clinical Performance of Various Bilayer Biomimetic Resin Composite Strategies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The primary outcomes are: surface luster, marginal staining, marginal adaptation, fracture, secondary caries, and postoperative sensitivity.
Study Overview
Brief Summary
The purpose of this study was to evaluate several bilayer biomimetic composite resin techniques in class I cavities over the course of 18 months in a randomized, double-blind clinical trial.
Detailed Description
To make resin composite restorations more resistant to cracking in cavities that are under a lot of stress, some have proposed using fiber reinforcement. This proposal is supported by numerous prior investigations that have demonstrated the efficacy of these repairs. By adjusting their orientation, fibers can control the pressures brought on by polymerization shrinkage. Therefore, marginal microleakage has been reduced in comparison to conventional resin composites. One way the material's fibers improve its structural characteristics is by preventing cracks from propagating. Composites are ideal for direct restorations of large cavities in healthy teeth and teeth that have had endodontic treatment because the fiber structure improves their mechanical properties. Moreover, in 2021, a comprehensive analysis of research found that resin composite restorations reinforced with fibers had better adaptability and higher fracture resistance than the standard ones.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Proper oral hygiene
- •Availability for follow-up periods
Exclusion Criteria
- •Endodontically treated or non-vital teeth
- •Parafunctional habits such as tooth clenching or grinding
Outcomes
Primary Outcomes
The primary outcomes are: surface luster, marginal staining, marginal adaptation, fracture, secondary caries, and postoperative sensitivity.
Time Frame: 18 months
Clinical assessment was carried out according to the World Dental Federation (FDI) by two calibrated evaluators at baseline and at 6, 9, 12, and 18 months. All of the restorations were ranked according to how well they met the criteria: clinically excellent or very satisfactory, clinically satisfactory, clinically satisfactory, or clinically inadequate. Clinical success was defined as a score of 1, 2, or 3, and failure was indicated by scores of 4 or 5. A powerful light source was used to conduct the visual inspection of the parameters. A magnifying dental loupe was utilized for this purpose. The Friedman test was conducted to evaluate intragroup comparisons of the same restoration outcomes through different follow-up periods. The Kruskal-Wallis test was utilized to assess intergroup comparisons between different restorations during the same follow-up period.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammed Abd El Ghany Mohammed
Doctor
Tanta University