NCT04401280已完成3 期
Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial
Rania Salah1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in White spot lesions dimension
研究概览
简要总结
the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
- •Absence of any active periodontal disease.
- •Written informed consent
排除标准
- •Known hypersensitivity/allergy to study products and/or materials used
- •teeth having deep carious lesions or extensive restorations
- •Unwillingness to be randomly assigned to 1 of the 3 treatment groups
- •Advanced periodontal disease.
研究组 & 干预措施
BiominF®
Active Comparator
Test group
干预措施: BiominF (Drug)
Novamin®
Active Comparator
Test group
干预措施: Novamin (Drug)
CPP-ACP
Active Comparator
Control group
干预措施: CPP-ACP (Drug)
结局指标
主要结局
Change in White spot lesions dimension
时间窗: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
Quantified using computer-assisted analysis based on digital intraoral photographs
次要结局
- change in lesion fluorescence(6 months: (Baseline, 1 week, 1 month, 3 months, 6 months))
研究者
Rania Salah
Clinical instructor and Principal investigator at conservative dentistry department
Alexandria University
研究点 (1)
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