Preformed Metal Crowns (PMCs) as a Treatment of Children With Hypomineralised Second Primary Molars (HSPM) Using the Hall Technique (HT)
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results.
研究概览
简要总结
Hypomineralised primary second molars are primary molars with a developmental disorder of the enamel. Preformed metal crowns already have good results for the treatment of caries on primary molars. In this study the aim is to investigate the clinical success and overall survival of preformed metal crowns as a treatment for hypomineralised primary molars. The crowns were placed using the Hall technique which is a simplified way of placing these crowns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 144 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 2-12 years
- •American Society of Anesthesiologists(ASA)-score I: healthy patient
- •hypomineralisation grade: 2-6
- •caries with an International Caries Detection and Assessment System (ICDAS)- score: 0-3
- •limited provoked pain complaint
排除标准
- •caries with an ICDAS-score: 4-6
- •pulpitis pain complaints
- •infection (clinical and/or radiographic)
- •>1/3 root resorption
- •allergies to the used materials
结局指标
主要结局
The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results.
时间窗: 1-2 year
The results are clinical acceptable when there are no clinical signs of infection of the tooth, no caries development or heavy bleeding of the gingiva (after probing).
The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable radiographical outcomes.
时间窗: 1-2 year
The outcomes are radiographical acceptable when no signs of infection or interproximal bone loss are seen on the radiographs.
The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable clinical outcomes.
时间窗: 1-2 year
The outcomes are clinically acceptable when there are no signs of infection (abscess) or caries.
次要结局
- The results can be affected by bruxism. Signs of bruxism will not mean failure. We will rate the wear as acceptable or successful. This bruxism will be measured by clinical signs of wear on the crowns.(1-2 year)
- The oral hygiene of the patient will be measured using the Simplified Oral Hygiene Index. The minimum value is 0: clean. The maximum value is 3: tooth surface covered with >2/3 soft dental plaque. The higher the score, the worse the outcome.(1-2 year)
研究者
Emily Mampay
Principal Investigator
Universitaire Ziekenhuizen KU Leuven