A Prospective Randomised Controlled Trial Investigating the Skeletal and Dental Effects of a Removable Brace That Works on the Upper and Lower Teeth at the Same Time Worn Part Time Versus Full Time
试验速览
- 阶段
- 不适用
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- remaining overjet measured with an orthodontic ruler
研究概览
简要总结
The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.
详细描述
Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.The investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).
The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.
The study will last for 15 months from the time the last patient is recruited. Participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be taken at 15months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class II div 1 malocclusion(upper front teeth lying more forward than lower front teeth with upper front teeth proclined),
- •Overjet(horizontal difference between upper and lower front teeth) measuring minimum of 7mm,
- •Male subjects 12--14 years at the start of treatment,
- •Female subjects 11--13 years at start of treatment,
- •Willingness of the patient and parent to participate in the study.
排除标准
- •No previous orthodontic treatment
- •No relevant medical history or craniofacial syndrome
结局指标
主要结局
remaining overjet measured with an orthodontic ruler
时间窗: outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period
the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment
Cephalometric Changes
时间窗: Outcome will be assessed after 12m of appliance wear and after 3 months of settling.
Both linear and angular cephalometric changes will be assessed over this timeframe.
次要结局
- Comparison of subjective and objective measures of appliance wear(12 months of appliance wear)