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临床试验/NCT06772051
NCT06772051招募中不适用

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

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Postoperative hypersensitivity/pulp status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •High caries risk patients with extremely poor oral hygiene
  • •Patients involved in orthodontic treatment or periodontal surgery,
  • •Patients with periodontally involved teeth (chronic

研究组 & 干预措施

Dentin etching and rinse (15 seconds etching)

Placebo Comparator

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

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

Dentin etching and rinse (5 seconds etching)

Active Comparator

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

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

Dentin self-etch

Placebo Comparator

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

干预措施: Resin composite restoration bonded using universal adhesive in self-etch mode (Procedure)

结局指标

主要结局

Postoperative hypersensitivity/pulp status

时间窗: Two years after restoration

The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria. This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.

Marginal adaptation

时间窗: Two years after restoration

The marginal adaptation will be evaluated through visual examination using a 250 µm probe and brief air drying. This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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