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临床试验/NCT07732790
NCT07732790已完成不适用

Clinical Evaluation of Resin Based Versus Giomer Fissure Sealants on MIH Affected Permanent Molars (RCT)

National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH.

研究概览

简要总结

This study aims to compare the effect of two types of fissure sealant a resin based and giomer based in molar incisor hypominerlisation first permanent molars

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, Outcomes Assessor)

入排标准

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

入选标准

  • • Apparently Healthy Children aged 6-12 years having at least one fully erupted First Permanent Molar (FPM) with MIH indicated for non-invasive fissure sealant.
  • Cooperative children.
  • Occlusal mild MIH defects (demarcated white, yellow or brown lesions)
  • sound surfaces and no incipient enamel caries, where moist control can be achieved.

排除标准

  • Children having hypomineralized FPMs with post eruption breakdown (PEB).
  • Cavitated carious lesions.
  • Restorations, fixed orthodontic appliances.
  • Enamel defect(s) due to a condition other than MIH.

结局指标

主要结局

Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH.

时间窗: 12 months

number of tooth with failed fissure sealant

时间窗: 12 months

Fissure sealants will be checked under artificial light with a dental mirror and straight explorer. The sealants that will receive "Alpha" or "Bravo" scores from all of the USPHS Criteria (anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries) will be classified as successful. On the other hand, "Charlie" score from one or more of the USPHS criteria will be considered as a failure.

次要结局

未报告次要终点

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rabab Mahmoud Abd Elhakam

Researcher of pediatric dentistry

National Research Centre, Egypt

研究点 (1)

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