Clinical Performance of Three Universal Adhesives in Posterior Restorations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations

Conditions
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Recurrent Caries

Intervention / Treatment
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* Other: Universal adhesives application
* Other: universal adhesive with bioactive properties
* Other: Fluoride-releasing universal adhesive


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Universal adhesive<br>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. | Other: Universal adhesives application<br>* 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.<br>|
| Active Comparator: Fluoride-releasing universal adhesive<br>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. | Other: Fluoride-releasing universal adhesive<br>* Fluoride-releasing universal adhesive<br>|
| Active Comparator: Universal adhesive with bioactive properties<br>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. | Other: universal adhesive with bioactive properties<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic, 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, Clinically excellent Clinically good Clinically sufficient Clinically unsatisfactory Clinically poor | 2 years after restorations application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic examination | Restorative materials will be examined radiographically every 6 months. | 2 years after restorations application |