NCT06772051

Clinical Evaluation of Short Dentin Etching

Short Dentin Etching With a Universal Adhesive: Two-Year Double-Blind Trial Comparing Etching Strategies and Durations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.

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 thirty adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on ninety Class I restorations. 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 study is scheduled to be conducted from December 2024 to December 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation. To determine the appropriate sample size, previous studies examining the clinical success rate of posterior Class I restorations restored using different adhesive strategies were considered. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 30 subjects (Three restorations per patient) was determined to be suitable.

Conditions

• Hypersensitivity Dentin
• Dental Restoration Failure of Marginal Integrity

Interventions

Type	Name	Description
PROCEDURE	Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)	Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)
PROCEDURE	Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)	Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)
PROCEDURE	Resin composite restoration bonded using universal adhesive in self-etch mode	Resin composite restoration bonded using universal adhesive in self-etch mode

Timeline

• Start date: 2024-12-24
• Primary completion: 2026-12-24
• Completion: 2026-12-30
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: Egypt