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临床试验/NCT06956651
NCT06956651尚未招募不适用

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Conservative Occlusal Restorations: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2025年9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
尚未招募
入组人数
40
主要终点
Clinical performance

研究概览

简要总结

The study compares two restorative materials to restore occlusal decay, offering the patients high-strength, high-durability restorations with antibacterial properties.

详细描述

There is no available evidence discussing the FIT SA restorative material in the restoration of occlusal lesions. This study aims to provide valuable insights into the clinical performance of this restorative material compared to the gold standard.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Posterior vital tooth with Class I caries.

排除标准

  • •Teeth with clinical symptoms of pulpitis, such as spontaneous pain.
  • •Pain or sensitivity to pressure.
  • •Non-vital teeth.
  • •Fractured or cracked teeth.
  • •Endodontically treated teeth.
  • •Periodontally affected teeth.

研究组 & 干预措施

Beautifil Flow Plus X F00

Active Comparator

Conventional flowable giomer restorative material

干预措施: Beautifil Flow Plus F00 (Other)

FIT SA

Experimental

Self Adhesive Flowable giomer restoration

干预措施: FIT SA (Other)

结局指标

主要结局

Clinical performance

时间窗: 18 months

Clinical performance using the Modified United States Public Health Service criteria, values: alpha (upper value - better outcome), charlie (lower value- worse outcome).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Ayman Kamal

Doctor

Cairo University

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