"A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From Molar Incisor Hypomineralization (MIH)" (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Gingival Health
研究概览
简要总结
It is a randomized clinical trial in which two different types of full coverage restoration in used to restore hypomineralized first permanent molar and protect the remaining tooth structure in patients with molar incisor hypomineralization ,one group is covered with CAD-CAM milled poly methyl methacrylate crowns and the other group is covered with cast metal copings (CAC) using nickel chromium alloy and there will be a nine months follow up.
详细描述
STUDY POPULATION Sixty (60) hypomineralized molars in patients suffering from molar incisor hypomineralization (MIH) will be randomly selected to share in this study from the out-patient clinic of pedodontics department, Faculty of dentistry, Ain Shams University.
Patient's approval :
All patients and parents will be informed in details about the nature of the investigation and the purpose of the study. They will agree to take part in the study and the parent will sign an informed consent form and the child will have an assent form.
All reasonable steps to protect the security of the personal information and privacy of the patient protected health information will be taken.
All patients will be notice about their privacy practices, their legal duties and their rights.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with molar incisor hypomineralization having at least one permanent fist molar affected and indicated for full coverage.
- •Patient is healthy and medically free.
- •Patient's age range from 6 to 12 years old.
- •The molar is free from any symptoms of pulp inflammation or has reversible pulpitis (Hypersensitivity).
排除标准
- •Patient who has any chronic systemic disease or immunocompromised.
- •Patient with special health care needs.
- •Molar which has irreversible pulpitis or pulp necrosis.
- •Molar which has periapical radiolucency and/or abscess or fistula or any periapical pathosis.
研究组 & 干预措施
PMMA crown Group
Hypomineralized first permanent molars in patients with molar incisor hypomineralization.
干预措施: CAD-CAM milled PMMA crown (Device)
Cast metal coping Group
Hypomineralized first permanent molars in patients with molar incisor hypomineralization.
干预措施: Cast metal coping using nickel chromium alloy (Other)
结局指标
主要结局
Gingival Health
时间窗: 9 months
the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .
Related quality of life: questionnaire
时间窗: 9 months
A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.
Recurrent caries
时间窗: 9 months
the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.
Marginal Integrity
时间窗: 9 months follow up
the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.
longevity
时间窗: 9 months
longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.
次要结局
未报告次要终点
研究者
Hagar Mahmoud Mohie
Teaching Assistant at MSA university
Ain Shams University