NCT04475419Unknown不适用
Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- pain after the restoration .Binary (yes or No)
研究概览
简要总结
Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns
详细描述
MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •.Children with molar incisor hypo mineralization in one fully erupted molar or more.
- •Age ranging from 7-12 years.
- •Cooperative children
- •Good general health
排除标准
- •Patients participating in other experiments .Patients with parents planning to move away within the following year.
- •Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
- •MIH-affected molars that have a very poor prognosis and require extraction.
- •First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.
结局指标
主要结局
pain after the restoration .Binary (yes or No)
时间窗: 12 MONTHS
questionnaire
次要结局
- health-related quality of life changes by the therapies(12 months)
- restoration quality Score index(12 months)
- Acceptability of the treatment Binary (yes or No)(12 months)
研究者
Mahmoud mohamed hassan
Assisstant lecturer
Cairo University
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