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 III)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain after the restoration Binary (yes or no )
研究概览
简要总结
The aim of this study is to compare 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Quadruple ( Participant, Care Provider, Investigator, Outcomes Assessor ) 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
Pain after the restoration Binary (yes or no )
时间窗: 12 month
Questionnaire
次要结局
- Health-related quality of life changes by the therapies(12 month)
- Acceptability of the treatment Binary (yes or no )(12 month)
- Restoration quality score index(12 month)
研究者
Nada Mahmoud Abd El-Azim Mohamed
Doctor/Dentist
Cairo University