NCT07715942进行中（未招募）不适用
Effect of Bioactive Resin Material Containing S-PRG Filler on White Spot Lesions: A Randomized Controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- White spot lesion area
研究概览
简要总结
the effect of bioactive resin composite containing S-PRG filler will be tested as the material of choice for attachments bonded on teeth prior to the use of orthodontic clear aligners compared to the conventionally used flowable composite material for the prevention of white spot lesions on enamel tooth surfaces
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young adult orthodontic patients
- •Class 1 malocclusion with mild to moderate crowding (<6 mm).
- •Non extraction treatment plan.
- •Optimum oral Hygiene before treatment.
- •A maximum of three restored teeth with either fillings or prosthesis.
排除标准
- •Patients with defective enamel, fluorosis, hypocalcification or enamel hypoplasia.
- •Extensive restorations.
- •Syndromes and Oro-facial anomalies.
- •Salivary gland diseases.
- •Patients who are pregnant, diabetic, or using mouth rinses or interacting medications, including antibiotic therapy.
结局指标
主要结局
White spot lesion area
时间窗: 6 months
It measures the area of enamel demineralization (in pixels) using QLF system
Mean of fluorescence loss (Delta F)
时间窗: 6 months
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound reflecting the amount of mineral loss using QLF system
次要结局
未报告次要终点
研究者
研究点 (1)
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