Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment With QLF Compared to Conventional Fixed Appliances: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Delta F
研究概览
简要总结
Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)
详细描述
White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients from both genders aged (17 - 24 years).
- •Class I malocclusion with mild to moderate crowding (≤ 5 mm).
- •Non-extraction treatment plan.
- •Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.
- •Maximum of 3 restored teeth.
- •Absence of defective enamel formation in the form of hypocalcification or hypoplasia.
排除标准
- •Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.
研究组 & 干预措施
Clear Aligner
Group 1 treated with clear aligners
干预措施: Orthodontic treatment with clear aligner (Device)
Fixed appliance
Group 2 treated with conventional fixed appliances
干预措施: Orthodontic treatment with clear aligner (Device)
结局指标
主要结局
Delta F
时间窗: 3 months
Incideance of Fluorescence loss
Lesion area
时间窗: 3 months
Incidence of the white spot lesion area
次要结局
- ΔR30(3 months)
- Number of new lesions(3 months)