Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hypersensitivity
研究概览
简要总结
The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.
详细描述
Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems.
For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.
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)
盲法说明
Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with MIH 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
Hypersensitivity
时间窗: 12 month
Questioning the patient and/or the parent (Clemenus et al,2017) Binary (yes, no)
次要结局
- Acceptability of the treatment(12 month)
研究者
Amal Ahmed Mohamed El Kot
doctor
Cairo University