Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Anchorage Loss Measured From 3-D Model Scanning
研究概览
简要总结
Research problem:
Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective. Microscrews despite their popularity however have no scientific evidence to support their use.
Aim:
To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance palatal arch 3) orthodontic micro-screws.
Hypothesis:
There is no difference in the amount of anchorage loss between the three methods of anchorage reinforcement.
Design:
Randomized clinical trial.
Setting: District General Hospital orthodontic department
Participants: 78 patients requiring "absolute anchorage".
Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for anchorage.
Method of investigation:
The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned to one of three groups of anchorage reinforcement
Outcome measures:
- Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points
- Patient perception of the different treatment methods, including surgical experience
Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive statistics and uni-variate tests will initially be done to explore the data. Final data analysis will involve the relevant multi-variate statistical modeling.
Dissemination: Conference proceedings, journal papers and the Cochrane oral health group.
详细描述
Research problem:
Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective. Microscrews despite their popularity however have no scientific evidence to support their use.
Aim:
To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance palatal arch 3) orthodontic micro-screws.
Hypothesis:
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 (Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Seventy-five children maximum anchorage cases, aged aged 12-17 referred from the General Dental Service to Chesterfield Royal Hospital will be selected to take part in this study.
- •Informed consent will be obtained.
排除标准
- •Previous orthodontic treatment,
- •Unwillingness to accept any of the three methods of treatment, OR
- •Syndromes or clefts.
研究组 & 干预措施
Extraoral anchorage
The intervention is the placement of Headgear, to be worn 100 hours per week
干预措施: Extraoral anchorage (Device)
Miniscrews
The intervention is the of miniscrews to supplement anchorage
干预措施: Miniscrews (Device)
Nance palatal arch
Anchorage supplemented by Nance palatal arch fixing molars together with an arch
干预措施: Nance (Device)
结局指标
主要结局
Anchorage Loss Measured From 3-D Model Scanning
时间窗: 2 years
次要结局
- Patient Perception of the Different Treatment Methods, Including Surgical Experience(2 years)
研究者
Jonathan Sandler
Principal Investigator
Chesterfield and North Derbyshire Royal Hospital
