Clinical Evaluation of Short Dentin Etching

Mansoura University

Status: Enrolling

Conditions: Hypersensitivity Dentin; Dental Restoration Failure of Marginal Integrity

Treatments: Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching); Procedure: Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching); Procedure: Resin composite restoration bonded using universal adhesive in self-etch mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06772051

A04012024 CD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 35 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Dentin etching and rinse (15 seconds etching)

Placebo Comparator group

Description:

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

Treatment:

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

Dentin etching and rinse (5 seconds etching)

Active Comparator group

Description:

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

Treatment:

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

Dentin self-etch

Placebo Comparator group

Description:

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

Treatment:

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