Treatment Adherence With Twin-Blocks for Correction of Class II Malocclusion - a Randomized Controlled Trial on Two Check-up Prescriptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals
研究概览
简要总结
To compare the effect of two control intervals (once every 4th week or once every 6th week) on the wear time of a Twin Block removable appliance.
详细描述
If the patient fulfill the inclusion criteria, they will be asked to participate in the study. After being informed about the study and the planned treatment, participants and their guardians will give their written consent to participate in the study.
Therafter they will be consecutively randomized into one of two groups with different control intervals, Group 1 (every 4th week) and Group 2 (every 6th week). They will recieve a clinical and radiological examination and then start treatment with a Twin Block appliance.
The Twin Block appliance will be fitted with a digital timer module to measure the wear time of the appliance objectively.
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
- Single (Outcomes Assessor)
盲法说明
The assessor will check outcome on blinded study models.
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients (ASA 1 and 2)
- •Overjet of 6 mm or more
- •Incomplete lip closure
排除标准
- •Severe chronic conditions such as asthma or allergies
- •Neuroopsychiatric disorders
- •Craniofacial syndromes
- •Previous orthodontic treatment
研究组 & 干预措施
Control group, controlled every 6th week
This group was controlled every 6th week, in accordance with what is deemed to be "golden standard" for treatment with a Twin Block orthodontic appliance.
干预措施: Twin block (Device)
Test group, controlled every 4th week
This group was controlled every 4th week, testing if a more frequent control interval would increase compliance with a Twin block orthodontic appliance.
干预措施: Twin block (Device)
结局指标
主要结局
Wear time of the Twin Block appliance, compared between participants randomized into two groups with different check up intervals
时间窗: From randomization to 12 months of treatment
To measure if the wear time of the Twin Block appliance would increase if the control interval increased from once every 6th week to once every 4th week. The wear time was registered using the TheraMon system, and was measured in hours per day.
次要结局
- Change in overjet, compared between participants randomized into two groups with different check up intervals(From randomization to treatment completion, up to 24 months.)
- Change in overbite, compared between participants randomized into two groups with different check up intervals(From randomization to treatment completion, up to 24 months.)
- Change in molar relationship, compared between participants randomized into two groups with different check up intervals(From randomization to treatment completion, up to 24 months.)