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临床试验/NCT06251921
NCT06251921招募中不适用

The Chromatic Evaluation of Universal Nano-hybrid Composites

Iuliu Hatieganu University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Clinical inspection of the restorations

研究概览

简要总结

The goal of this clinical trial is to evaluate the preheating effect of a group shade resin-based composite. The evaluation will be done on Ryge criteria. The main question it aims to answer is if there is a difference in time between preheated and non-heated resin-based composites in the oral cavity. Participants will be given treatment for cavities class 2 on premolars and molar and will come for recall at 24h, 1 week, 6 weeks, 3 months, 6 months, and 1 year.

详细描述

The participants in the study will be adult patients (over 18 years old). Each patient will receive 2 restorations on premolars or molars, class 2, and medium cavities. The restorations will be performed under isolation with rubber-dam, and restored with preheated or not-heated resin-based composite. The occlusion will be tested and they will be notified to come for recall in order to make the evaluation of the restorations.

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
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Permanent dentition
  • The OHI index = 0
  • Non-smoking patient
  • The patient has a healthy diet
  • The patient has parafunction
  • The antagonist tooth is healthy / with direct restorations
  • The caries are situated on proximal surfaces on premolars, molars
  • The cavities have a medium depth

排除标准

  • Temporary dentition
  • The OHI index >= 1
  • The patient is smoker
  • The patient has an unhealthy diet
  • The patient suffers from bruxism, clenching
  • The antagonist tooth has an indirect restoration
  • The caries are situated on canines or incisors
  • The cavities have a deep or shallow depth

结局指标

主要结局

Clinical inspection of the restorations

时间窗: 1 year

The blind observer will clinically inspect the restorations , following the Ryge scale criteria

次要结局

未报告次要终点

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prodan Corina Mirela

Dr.

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (2)

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