The Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overbite
研究概览
简要总结
The aim of this study was to evaluate and compare the effect of myofunctional trainer T4K versus twin block functional appliance on the dentoalveolar changes in children with class II division I malocclusion
详细描述
This study was a parallel arm randomized comparative clinical trial including 20 healthy children age ranged from 9-12 years showing Angle's class II division I malocclusion due to mandibular retrusion. Preoperative photographs, radiographs and study casts were taken, children were randomly assigned into two groups according to the appliance used; Group 1: T4k, and Group II: twin block. Follow up was done every 4 weeks for 9 months. Postoperative cephalometric X ray, study casts and photographs were retaken for measurements and comparison.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This study was a double-blind study, as the participant and the outcome assessors were blinded to the type of treatment.
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angle's class II division I malocclusion due to mandibular retrusion depending on clinical judgement and confirmed with the lateral cephalometric X-ray.
- •Parental written consent was secured.
排除标准
- •Patients with mandibular shifts.
- •Patients with severe crowding.
- •Patients with anterior open bite.
- •Patients with posterior crossbite.
- •Patients with any peri-oral habits.
- •Patients who had received any previous orthodontic or orthopaedic treatments.
研究组 & 干预措施
T4k
干预措施: T4k Appliance (Device)
Twin block
干预措施: Twin block appliance (Device)
结局指标
主要结局
Overbite
时间窗: 9 months
the extent of vertical (superior-inferior) overlap of the maxillary central incisors over the mandibular central incisors, measured relative to the incisal ridges. This was assessed on study casts
Dento-alveolar changes
时间窗: 9 months
This was assessed using lateral cephalometric xrays. Inclination of of maxillary incisor was assessed by measuring the angle to Frankfurt horizontal plane
Overjet
时间窗: 9 months
the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors was measured on study casts.
Dento-alveolar changes
时间窗: baseline
This was assessed using lateral cephalometric xrays. Inclination of of maxillary incisor was assessed by measuring the angle to Frankfurt horizontal plane
Overjet
时间窗: baseline
the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors was measured on study casts.
Overbite
时间窗: baseline
the extent of vertical (superior-inferior) overlap of the maxillary central incisors over the mandibular central incisors, measured relative to the incisal ridges. This was assessed on study casts
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Dental Public Health clinical instructor and statistician
University of Alexandria