Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Aesthetic, functional and biological properties for composite restorations
研究概览
简要总结
This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria.
详细描述
The description of the experimental design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations.
No advertisement will be made for participant recruitment, forming a sample of convenience. Each patient will sign a consent form before participating in the current study. The study will be conducted from November 2022 to November 2024 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on a previous study with a similar study design. Parameters including a significance level of 5% (p < 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. Allowing for a 20% drop-out rate, the total sample size was set at 30 cases.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients will have at least 3 posterior teeth with carious lesions of ICDAS score 4, or
- •The teeth will have to be vital, without spontaneous pain and/or mobility.
- •Patients must have a good oral hygiene.
- •Patients with normal and full occlusion.
排除标准
- •High caries risk patients with extremely poor oral hygiene.
- •Patients with abutments.
- •Patients with heavy bruxism habits and clenching.
结局指标
主要结局
Aesthetic, functional and biological properties for composite restorations
时间窗: 2 years after restorations application
Composite restorations will be clinically assessed based on International dental federation (FDI) criteria. Scores from 1 to 5, 1. Clinically excellent 2. Clinically good 3. Clinically sufficient 4. Clinically unsatisfactory 5. Clinically poor
次要结局
- Radiographic examination(2 years after restorations application)
