NCT07718191尚未招募不适用
Clinical Evaluation of Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- evaluation of self-reported pain
研究概览
简要总结
The aim of this clinical trial is to evaluate the clinical success of 3D printed Indirect hybrid resin restorations in the hypomineralized first permanent molars.
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
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged from 7 years to 11 years
- •MIH-TNI 2 or 4
- •No past dental treatment for the hypomineralized first permanent mandibular molars.
- •Caries lesions that include the occlusal surface.
排除标准
- •The presence of systemic disease, physical or mental disability.
- •Any potential confounding enamel defects i.e., amelogenesis imperfecta.
- •Uncooperative children.
- •A history of allergic reactions to local anesthetics or some components of restorative materials
- •History of spontaneous pain.
- •Presence of clinical or radiographic signs of pulp necrosis (Fistula/abscess, internal or external root resorption, mobility of the tooth, and swelling).
结局指标
主要结局
evaluation of self-reported pain
时间窗: 12 months
Self-reported pain was assessed considering each MIH affected FPM included in the study, using the faces pain scale-revised (FPS-R) before and after the restoration. This scale is made up of six faces, each representing an increase in the degree of pain fromleft to right. The scores of the faces are 0, 2, 4, 6, 8, and 10
次要结局
- percentage of clinical survival of restoration(12 months)
研究者
Maha Elhabbak
Assistant Lecturer
Cairo University
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