Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Molar intrusion
研究概览
简要总结
Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD) or orthodontic fixed appliances incorporating two buccal TADs
详细描述
Participants will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the inclusion and exclusion criteria will be invited to participate. After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. In order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (See later for details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction
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
Outcome assessor will be blind to allocation
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AOB of 1-6mm
- •Aged between (12 and 40 years).
- •Able to consent.
- •Patient due to undergo orthodontic treatment with fixed orthodontic braces.
排除标准
- •Patient has previously had upper first permanent molar extraction.
- •Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.
- •Patient with bone disease or taking medications that affect the bone quality or nature.
- •Patient with an active digit sucking habit.
- •Pregnant or breastfeeding women
研究组 & 干预措施
Single Palatal TAD
Single Palatal TAD for orthodontic molar intrusion
干预措施: Single Palatal TAD (Device)
Two buccal TADs
Two buccal TADs for orthodontic molar intrusion
干预措施: Two buccal TADs (Device)
结局指标
主要结局
Molar intrusion
时间窗: 9-12 months after treatment commences
Amount of upper molar intrusion measured in mms on cephalometric radiograph
次要结局
- Overbite (vertical overlap of anterior teeth)(9-12 months after treatment commences)
- Patient Experience(9-12 months after treatment commences)
研究者
Peter Mossey
Professor
University of Dundee