Clinical Evaluation of Short Dentin Etching

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Postoperative hypersensitivity/pulp status [Time frame: Two years after restoration]
• Marginal adaptation [Time frame: Two years after restoration]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry, Mansoura University, Egypt — Al Mansurah

Identifiers

NCT: NCT06772051 · A04012024 CD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗