Analysis of the Efficacy of AngelAligner A6 Mandibular Advancer and Twin Block in the Treatment of Class II Malocclusion in Growing Patients: a Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ANB (°)
研究概览
简要总结
To analyze mandibular advancement between the traditional Twin Block and the Angel Aligner A6 mandibular advancement clear aligners using cephalometric analysis in growing patients and a repeatable and reproducible digital measurement technique.
详细描述
This study compared three early orthodontic treatments for Class II division 1 malocclusion in 60 growing patients (mean age: 12.4 ± 1.3 years): Twin Block, standard Angel Aligner, and Angel Aligner A6 with mandibular advancement.
After 10 months, both Twin Block and A6 showed greater skeletal correction and mandibular advancement than standard aligners, achieving higher rates of Class I correction. The A6 group also had the shortest overall treatment time.
Cephalometric analyses were performed using a digital and reproducible measurement technique. For each patient, lateral cephalograms were taken before treatment (T0) and after treatment (T1, after the functional phase or aligner completion). Thus, a total of 120 lateral cephalograms were analysed. The following skeletal, dental, and soft tissue parameters were analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 9 and 14 years with late mixed or early permanent dentition
- •Class II/1 malocclusion (molar relationship ≥ half-cusp Class II and overjet ≥ 5 mm)
- •ANB angle greater than 5º
- •SNB lower than 78º
- •CVMS 2-3, a growing patients.
排除标准
- •Previous orthodontic treatment or orthognathic surgery
- •Patients with severe malformations or syndromes
- •Extraction treatment.
研究组 & 干预措施
AngelAligner A6 Mandibular Advancer
Mandibular advancement with aligners uses specially designed appliances to position the lower jaw forward, improving jaw alignment and correcting Class II malocclusion in growing patients. Aligner replacement was performed at 10-day intervals.
干预措施: AngelAligner A6 Mandibular Advancer (Device)
Twin block
The Twin Block is a removable functional orthodontic appliance used to correct Class II malocclusion by advancing the mandible. It consists of upper and lower acrylic plates with bite blocks that interlock at a specific angle, guiding the lower jaw forward during closure. It is most effective in growing patients to improve jaw relationship and facial profile. The Twin Block appliance was worn for a period of 10 months, with a minimum of 14-16 hours per day, including night hours.
干预措施: Twin Block (Device)
Clear aligners
Class II correction with aligners (without mandibular advancement) involves the use of clear sequential aligners to improve dental alignment and occlusion by moving teeth into a more favorable position. The correction is achieved through controlled tooth movements without actively repositioning the mandible forward. Aligner replacement was performed at 10-day intervals.
干预措施: Clear aligners (Device)
结局指标
主要结局
ANB (°)
时间窗: 10 months
Point A-nasion-point B angle (ANB): relationship between the upper and lower jaws
Wits appraisal (AO-BO)
时间窗: 10 months
projecting points A and B in two perpendicular lines, along the functional occlusal plane
次要结局
未报告次要终点
研究者
Elena Calzadilla Suárez
Principal Investigator
University of Salamanca