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临床试验/NCT04679220
NCT04679220已完成不适用

36-Months Clinical Evaluation of Preheated Resin Composite

Mansoura University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

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

Active Comparator

Patients received Non-heated nanofilled resin composite on one side of the mouth

干预措施: Preheating (Procedure)

Preheated Resin Composite group

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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