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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Universal adhesive | Placebo Comparator | 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. |
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| Fluoride-releasing universal adhesive | Active Comparator | 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. |
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| Universal adhesive with bioactive properties | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Universal adhesives application | Other | 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. |
| 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,
| 2 years after restorations application |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic examination | Restorative materials will be examined radiographically every 6 months. | 2 years after restorations application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yassmine F El-Sayed, Assis.Lec | Contact | 01004855670 | yassmine@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Yassmine F El-Sayed, Assis.Lec | Faculty of Dentistry, Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry-Mansoura university | Recruiting | Al Mansurah | Dakahia | 35516 | Egypt |
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Data will be available within 6 Months for 2 years
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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.
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| universal adhesive with bioactive properties | Other | 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. |
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| Fluoride-releasing universal adhesive | Other | Fluoride-releasing universal adhesive |
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