Clinical Evaluation of Short Dentin Etching

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Postoperative hypersensitivity/pulp status [Срок оценки: Two years after restoration]
• Marginal adaptation [Срок оценки: Two years after restoration]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• High caries risk patients with extremely poor oral hygiene

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

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

Идентификаторы

NCT: NCT06772051 · A04012024 CD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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