NCT05127343Unknown不适用
One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 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
- 是
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.
研究组 & 干预措施
Resin based sealant (Ultraseal XT Hydro)
Active Comparator
干预措施: Sealing deep pits and fissures (Procedure)
Glass ionomer based sealant (Fugi Triage)
Active Comparator
干预措施: Sealing deep pits and fissures (Procedure)
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
Ghada Mohamed El-Amir Hashim Sediek
Master's Degree student- Faculty of Dentistry
Cairo University
研究点 (1)
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