Recurrent Caries
Conditions
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.
Interventions
OTHERUniversal adhesives application
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.
OTHERuniversal adhesive with bioactive properties
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.
OTHERFluoride-releasing universal adhesive
Fluoride-releasing universal adhesive
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Each patient will receive the three universal adhesives with the same restorative material randomly in three posterior teeth. All the materials will be used according to their manufacturers' instructions.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* High caries risk patients with extremely poor oral hygiene. * Patients with abutments. * Patients with heavy bruxism habits and clenching.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Radiographic examination | 2 years after restorations application | Restorative materials will be examined radiographically every 6 months. |
Countries
Egypt
Contacts
Primary ContactYassmine F El-Sayed, Assis.Lec
Outcome results
None listed