NCT01329731已完成4 期
White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months
Gaba International AG1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- WSL-size change
研究概览
简要总结
The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.
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, Investigator)
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Healthy volunteers (≥11 years) scheduled for bracket removal
- •≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding
排除标准
- •Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study
- •Known hypersensitivity or allergy to placebo gel ingredients
- •Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis
- •Any illness/condition potentially affecting the study outcome at investigator's discretion
- •Known pregnancy or breast feeding during the course of the study
研究组 & 干预措施
Test
Active Comparator
1.25% fluoride (elmex® gelée)
干预措施: elmex® gelée (Drug)
Control
Placebo Comparator
0% fluoride (negative control)
干预措施: negative control (placebo) (Drug)
结局指标
主要结局
WSL-size change
时间窗: 12 weeks
Changes in size of white spot lesions (WSL) at 12 weeks
次要结局
- WSL-size change(Baseline up to 24 weeks)
- WSL-brightness change(Baseline up to 24 weeks)
- WSL index on all upper front teeth(Baseline up to 24 weeks)
- Caries activity(Baseline up to 24 weeks)
- Plaque index (Silness and Löe 1964)on all upper front teeth(Baseline up to 24 weeks)
- Gingival bleeding index on all upper front teeth(Baseline up to 24 weeks)
- DMFT index: Dental health of all teeth(Baseline, 24 weeks)
研究者
研究点 (1)
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