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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
The adhesive will be used according to their manufacturer's instructions. Selective etching for enamel will be applied for 15 seconds, followed by rinsing and gentle air drying. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
The adhesive will be used according to their manufacturer's instructions. Enamel and dentin will be cleaned using clean and boost for 10 seconds, rinsed and gently dried. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
Faculty of dentistry-Mansoura university
Al Mansurah, Dakahia, Egypt
RECRUITINGAesthetic, functional and biological properties for composite restorations
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
Time frame: 2 years after restorations application
Radiographic examination
Restorative materials will be examined radiographically every 6 months.
Time frame: 2 years after restorations application
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Fluoride-releasing universal adhesive