NCT06265116

One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations

One-Step Universal Adhesives: A 3-year Randomized Comparative Clinical Trial in Class II Composite Restorations

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Dental Caries Class II
• Marginal Integrity of Composite Restorations With Universal Adhesives

Interventions

Type	Name	Description
OTHER	One-step universal adhesive	Each patient will receive a class II restoration using the corresponding group adhesive

Timeline

• Start date: 2024-01-23
• Primary completion: 2027-01-23
• Completion: 2027-01-30
• First posted: 2024-02-20
• Last updated: 2025-05-08

Locations

1 site across 1 country: Egypt