Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration (Randomized Control Study) .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- • Little irregularity index
研究概览
简要总结
The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners
详细描述
This study will employ a two-arm parallel randomized clinical trial design with an allocation ratio of 1:1. The study will include participants aged 16 to 23 years with mild to moderate anterior lower crowding and Class I Angle malocclusion, presenting with a full set of teeth excluding wisdom teeth. Eligible participants will be randomly assigned to either the intervention group, receiving LLLT in addition to clear aligner therapy, or the control group, receiving clear aligner therapy alone.
Intervention:
The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 23 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A well-behaved, compliant, and motivated patient.
- •Patients from 16 to 23 years old .
- •Patients with mild to moderate anterior lower crowding.
- •Full complement of teeth (except for wisdom teeth).
- •Class I Angle malocclusion .
排除标准
- •Patients with missed anterior teeth .
- •Class II or III Malocclusion (dental or skeletal ) .
- •Any systemic diseases that may interfere with assigned treatment plan .
- •Periodontal affection especially at lower anterior teeth .
结局指标
主要结局
• Little irregularity index
时间窗: through study completion, an average of 6 months
The Little Irregularity Index is a quantitative method used to assess the degree of dental crowding. It measures the linear displacement of the contact points of the mandibular anterior teeth (canine to canine) from their ideal positions. This measurement is taken before and after orthodontic treatment using scanned 3D models, allowing for an objective evaluation of alignment improvement.
次要结局
- • Tooth movement accuracy(through study completion, an average of 6 months)
- • Treatment time(through study completion, an average of 6 months)
- • Number of aligners(through study completion, an average of 6 months)
- • Patient comfort and satisfaction(through study completion, an average of 6 months)
- • Digital cast accuracy(through study completion, an average of 6 months)
- • Refinement rate(through study completion, an average of 6 months)
- • Software predictability(through study completion, an average of 6 months)
研究者
Huda Abdelhakim
Doctor
Faculty of Dental Medicine for Girls