36-Months Clinical Evaluation of Preheated Resin Composite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Percentage % of patients with marginal staining
研究概览
简要总结
Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.
详细描述
The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 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 the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects.
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
- 20 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with primary caries involving occlusal surface only with ICDAS 2 and 3
- •Patients with cavities no more than one-third of the intercuspal distance
- •Patients must have a good oral hygiene;
- •Patients with tooth gives 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 periodontitis)
- •Patients with abutments should be excluded.
- •Patients with heavy bruxism habits and clenching
研究组 & 干预措施
Non-heated Resin Composite group
Patients received Non-heated nanofilled resin composite on one side of the mouth
干预措施: Preheating (Procedure)
Preheated Resin Composite group
Patients received preheated nanofilled resin composite on the other side of the mouth
干预措施: Preheating (Procedure)
结局指标
主要结局
Percentage % of patients with marginal staining
时间窗: 3 years after restoration procedure
Percentage of marginal staining in patients was clinically assessed using World Dental Federation FDI parameters using a scale from 1 to 5 scores (clinically very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor)
次要结局
未报告次要终点
