跳至主要内容
临床试验/NCT05127343
NCT05127343Unknown不适用

One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
试验地点
2
主要终点
Retention rate

研究概览

简要总结

The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
  • Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
  • Cooperative patients who will allow the clinical applications

排除标准

  • Uncooperative behaviour limiting the use of sealants throughout the procedure.
  • Patients with history of medical diseases, drug therapies or any other serious relevant problem.
  • Patients with well coalesced pits and fissures
  • Patients allergic to sealant material
  • Patients who underwent orthodontic treatment.

结局指标

主要结局

Retention rate

时间窗: Change from baseline at 3, 6, 12 months

* Full retention (FR): The material is fully present on the occlusal surfaces * Partially lost (PL): The material is present, but as a result of either wear or loss of the material, part of the previously sealed fissure, was exposed. * Totally lost (TL): No trace of the material to be detected on the surface

次要结局

  • Caries formation(Change from baseline at 3, 6, 12 months)

研究者

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

Ghada Mohamed El-Amir Hashim Sediek

Master's Degree student- Faculty of Dentistry

Cairo University

研究点 (2)

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