Impact of Lingual Attachment Placement on White Spot Lesion Development in Clear Aligner Orthodontic Patients : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- White spot lesion area
研究概览
简要总结
White spot lesions (WSLs) are a common esthetic complication during orthodontic treatment. While clear aligners (CAs) generally reduce WSL risk compared to fixed appliances, composite attachments remain plaque-retentive sites. This two-arm clinical trial investigated the effect of shifting attachments to lingual surfaces on WSL development.
详细描述
A randomized controlled trial was conducted on 52 patients (18-35 years) undergoing CA therapy. Participants were allocated to two groups (n=26) for each: conventional buccal attachments (control) and lingual/palatal attachments (intervention). WSLs and plaque were assessed at baseline (T0) and six months (T1) using quantitative light-induced fluorescence (QLF). Outcomes included lesion area (pixels), mean fluorescence loss (ΔF), maximum depth (ΔFmax), and plaque index (ΔR30). Statistical analysis employed paired and independent t-tests, chi-square, and multivariable regression (α<0.05).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically fit young adults
- •The patient should have mild to moderate crowding or spacing of teeth.
- •The treatment plan should be non-extraction.
- •Patients should have optimum oral hygiene before beginning the treatment.
- •The patient may have a maximum of three teeth with either fillings or dental prostheses.
- •(According to the British national institute of health, NIH 2016).
排除标准
- •Patients with defective enamel, generalized enamel disorder, or extensive dental restorations.
- •Patients with syndromes or orofacial anomalies.
- •Patients with salivary gland diseases or taking medications that may affect oral flora or salivary functions.
- •Patients who are pregnant or diabetic.
- •Patients use mouth rinses or any extra form of fluoride other than toothpaste.
研究组 & 干预措施
Lingual attachment participants
In this group composite attachments were placed on the lingual/palatal surfaces of teeth for clear aligner therapy
干预措施: Lingual attachment participants (Other)
Buccal attachment participants
In this group composite attachments were placed on the buccal surfaces of teeth for clear aligner therapy
干预措施: Lingual attachment participants (Other)
结局指标
主要结局
White spot lesion area
时间窗: Before treatment and after 6 months
Lesion area measured in pixels
Delta F
时间窗: Before treatment and after 6 months
Loss of fluorescence which reflects loss in minerals
Delta F max
时间窗: Before treatment and after 6 months
Measures the deepest point of the lesion
次要结局
- Plaque measurement(Before treatment and after 6 months)