Clinical Performance of Three Universal Adhesives in Posterior Restorations
- Conditions
- Recurrent Caries
- Interventions
- Other: Fluoride-releasing universal adhesiveOther: Universal adhesives applicationOther: universal adhesive with bioactive properties
- Registration Number
- NCT05696431
- Lead Sponsor
- Mansoura University
- Brief Summary
This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria.
- Detailed Description
The description of the experimental design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations.
No advertisement will be made for participant recruitment, forming a sample of convenience. Each patient will sign a consent form before participating in the current study. The study will be conducted from November 2022 to November 2024 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on a previous study with a similar study design. Parameters including a significance level of 5% (p \< 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. Allowing for a 20% drop-out rate, the total sample size was set at 30 cases.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Patients will have at least 3 posterior teeth with carious lesions of ICDAS score 4, or 5.
- The teeth will have to be vital, without spontaneous pain and/or mobility.
- Patients must have a good oral hygiene.
- Patients with normal and full occlusion.
- High caries risk patients with extremely poor oral hygiene.
- Patients with abutments.
- Patients with heavy bruxism habits and clenching.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fluoride-releasing universal adhesive Fluoride-releasing universal adhesive After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a Fluoride-releasing universal adhesive. Universal adhesive Universal adhesives application After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a universal adhesive as control group. Universal adhesive with bioactive properties universal adhesive with bioactive properties After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used.This group will receive a universal adhesive with bioactive properties.
- Primary Outcome Measures
Name Time Method Aesthetic, functional and biological properties for composite restorations 2 years after restorations application Composite restorations will be clinically assessed based on International dental federation (FDI) criteria.
Scores from 1 to 5,
1. Clinically excellent
2. Clinically good
3. Clinically sufficient
4. Clinically unsatisfactory
5. Clinically poor
- Secondary Outcome Measures
Name Time Method Radiographic examination 2 years after restorations application Restorative materials will be examined radiographically every 6 months.
Trial Locations
- Locations (1)
Faculty of dentistry-Mansoura university
🇪🇬Mansoura, Dakahia, Egypt