Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy: 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
- 24
- 试验地点
- 1
- 主要终点
- White Spot Lesions
研究概览
简要总结
Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions.
Material and methods:
Type: Prospective, randomized split mouth controlled study.
Interventions:
Intervention Group (Experimental Side):
•Application of fluoride-releasing composite
Control Group (Control Side):
•Application of conventional composite
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions
Secondary Outcomes:
- Periodontal Ligament (PDL) Health
- Gingival Bleeding and Inflammation
详细描述
Aim of the Study:
The aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group.
Material and methods:
Study Design:
Each participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments.
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).
排除标准
- •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.
研究组 & 干预措施
Intervention Group (Experimental Side)
application of fluoride-releasing composite on the indicated side of the mouth as attachments.
干预措施: Application of fluoride-releasing composite (Other)
Control Group (Control Side)
application of conventional composite as attachments.
干预措施: Application of conventional composite (Other)
结局指标
主要结局
White Spot Lesions
时间窗: six months
Incidence and Severity of White Spot Lesions Measured at baseline, third (T1) and sixth (T2) months, by Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
次要结局
- Periodontal Ligament (PDL) Health(six months)
- Gingival Bleeding and Inflammation(six months)
研究者
Mohammed Amer
Dentist Mohammed Amer
Mansoura University