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to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split-mouth design. A total of forty-eight adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Outpatient clinic at Faculty of Dentistry, Mansoura University.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The protocol of the study was approved by Mansoura University's ethics committee before initiation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bis-GMA-containing, HEMA-containing, one-step universal adhesive. | Active Comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems |
|
| Bis-GMA-free, HEMA-containing, one-step universal adhesive | Active Comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems |
|
| Bis-GMA- free, HEMA-free, acrylic-based one-step universal adhesive | Active Comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems |
|
| Bis-GMA- containing, HEMA-containing, amide-based one-step universal adhesive | Active Comparator | Each patient will randomly receive one class II restoration with one of the tested restorative systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-step universal adhesive | Other | Each patient will receive a class II restoration using the corresponding group adhesive |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of functional and biological properties for each group | Percentage of functional and biological properties that will be clinically assessed using recently revised World Dental Federation parameters for each restorative system group | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omar Abd El-Fattah Abd El-Maksoud | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
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