Clinical Evaluation of Short Dentin Etching

NCT ID: NCT06772051

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-24
• Study Completion Date: 2026-12-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dentin etching and rinse (15 seconds etching)

The dentin in the pulpal floor in this group will receive phosphoric acid etching for 15 seconds followed by rinsing and drying before universal adhesive application

Group Type: PLACEBO_COMPARATOR

Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)

Intervention Type: PROCEDURE

Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)

Dentin etching and rinse (5 seconds etching)

The dentin in the pulpal floor in this group will receive phosphoric acid etching for 5 seconds followed by rinsing and drying before universal adhesive application

Group Type: ACTIVE_COMPARATOR

Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)

Intervention Type: PROCEDURE

Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)

Dentin self-etch

The dentin in the pulpal floor in this group will receive universal adhesive application in self-etch mode without prior phosphoric acid etching

Group Type: PLACEBO_COMPARATOR

Resin composite restoration bonded using universal adhesive in self-etch mode

Intervention Type: PROCEDURE

Resin composite restoration bonded using universal adhesive in self-etch mode

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

Resin composite restoration bonded using universal adhesive in self-etch mode

Resin composite restoration bonded using universal adhesive in self-etch mode

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with three primary occlusal caries of upper or lower posterior teeth.
• Patients must have a good oral hygiene;
• Patients with tooth gives a positive response to testing with an electric pulp tester
• Patients with normal and full occlusion,
• Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria

• High caries risk patients with extremely poor oral hygiene

• Patients involved in orthodontic treatment or periodontal surgery,
• Patients with periodontally involved teeth (chronic

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoda S Ismail, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Mansoura University, Egypt

Locations

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Dakahliya, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hoda S Ismail, Lecturer

Role: CONTACT

hoda_saleh@mans.edu.eg

01005395069

Facility Contacts

Hoda S Ismail, Lecturer

Role: primary

Other Identifiers

A04012024 CD

Identifier Type: -

Identifier Source: org_study_id