Clinical trial NCT06772051: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypersensitivity Dentin
Dental Restoration Failure of Marginal Integrity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will receive three restorations in posterior teeth randomly on three different quadrants, each tooth will be restored with one of the three tested adhesive strategies. All materials will be used according to manufacturers' instructions
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative hypersensitivity/pulp status
timeFrame: Two years after restoration
measure: Marginal adaptation
timeFrame: Two years after restoration
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University, Egypt
state: Dakahliya
Study officials:
affiliation: Faculty of Dentistry, Mansoura University, Egypt
name: Hoda S Ismail, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: