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临床试验/NCT07688343
NCT07688343进行中(未招募)不适用

Two-Year Clinical Performance of Different Ion-Releasing Restorative Systems Applied in Class II Cavities

Mansoura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6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
进行中(未招募)
入组人数
40
试验地点
1
主要终点
difference between baseline and after two years of evaluation

研究概览

简要总结

Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared

详细描述

This randomized clinical trial aims to evaluate the clinical performance of different ion-releasing restorative systems used in Class II posterior cavities over a two-year follow-up. Patients must be in adults (not less than 18 years old), able to attend regular follow-up visits, presenting with at least four carious class II posterior teeth requiring restoration. Pregnant patients will be excluded.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • at least 4 carious posterior teeth

排除标准

  • pregnancy - not able to attend for regular follow-up -smokers or very bad oral hygiene

研究组 & 干预措施

conventional bulk fill restorative system

Experimental

posterior cavities restored with conventional bulk fill restorative system applied in single increment according to the manufacturer's instructions

干预措施: conventional bulk fill restorative system (Procedure)

ion- releasing restorative system 1

Experimental

posterior cavities restored with ion-releasing restorative system applied 1 in single increment according to the manufacturer's instructions

干预措施: ion-releasing restorative system 1 (Procedure)

ion-releasing restorative system 2

Experimental

posterior cavities restored with ion-releasing restorative system 2 applied in single increment according to the manufacturer's instructions

干预措施: ion-releasing restorative system 2 (Procedure)

ion-releasing restorative system 3

Experimental

posterior cavities restored with ion-releasing restorative system 3 applied in single increment according to the manufacturer's instructions

干预措施: ion-releasing restorative system 3 (Procedure)

结局指标

主要结局

difference between baseline and after two years of evaluation

时间窗: baseline to two-years

Changes in restoration performance according to the modified Federation Dentaire Internationale (FDI) criteria from baseline to 2 years. Scores range from 1 to 5, where lower scores indicate better clinical performance and higher scores indicate poorer clinical performance.

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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