The Role of Fluoride Varnish Application in Preventing White Spot Lesions During Clear Aligner Treatment: A Controlled Split-Mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence and Severity of White Spot Lesions
研究概览
简要总结
aim of study: is to compare the effect of the fluoride varnish application on the prevention of white spot lesions (WSLs) during clear aligner therapy
Design Details: Each participant will have one side of the mouth assigned to the fluoride varnish intervention, while the contralateral side will serve as the control without fluoride varnish.
Outcomes:
Primary outcome: Incidence and Severity of White Spot Lesions Measured before and after six months using Laser fluorescence (DIAGNOdent)
Secondary Outcome:
Periodontal Ligament (PDL) Health using pocket Depth Index (PDI) Gingival Bleeding and Inflammation using bleeding on Probing Index (BOP)
详细描述
aim of study: is to compare the effect of the fluoride varnish application on the prevention of white spot lesions (WSLs) during clear aligner therapy in comparison to a split mouth-controlled group
Sample size calculation:
The sample size was calculated using G* power software (version3.1.9.7) and was designed to have a power of 85% assuming a type I statistical error of 5% and a one tailed statistical test with an effect size f= 0.7730012 based on the study of Najafi et al. The means and standard deviation of the DIAGNOdent score of the varnish and control groups after six months were 1.23 ±0.45 and 1.78±0.90. The calculated sample size will be 25 patients. The sample size will be increased to include 30 patients to avoid any drop out.
Material and methods:
- Initial Oral Scan:
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
- None
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 16-24 years.
- •Good general and oral health.
- •Mild dental crowding per arch (≤ 4 mm).
- •Eruption of all permanent dention excluding third molar
排除标准
- •Allergy to fluoride material
- •Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- •Patients with Cleft lip and palate
- •Previous orthodontic treatment
- •dental fluorosis.
- •hypocalcified teeth or visible demineralization
结局指标
主要结局
Incidence and Severity of White Spot Lesions
时间窗: Six months
Incidence and Severity of White Spot Lesions Measured before and after six months using Laser fluorescence (DIAGNOdent)
次要结局
- Periodontal Ligament (PDL) Health(Six moths)
- Gingival Bleeding and Inflammation(Six months)
研究者
Jalal Alshami
Dentist Jalal-Alshami
Mansoura University