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临床试验/NCT00995436
NCT00995436已完成不适用

Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics

Chesterfield and North Derbyshire Royal Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2008年7月1日最近更新:
适应症
干预措施

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:

  1. Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points
  2. 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

Active Comparator

The intervention is the placement of Headgear, to be worn 100 hours per week

干预措施: Extraoral anchorage (Device)

Miniscrews

Active Comparator

The intervention is the of miniscrews to supplement anchorage

干预措施: Miniscrews (Device)

Nance palatal arch

Active Comparator

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

发起方
Chesterfield and North Derbyshire Royal Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jonathan Sandler

Principal Investigator

Chesterfield and North Derbyshire Royal Hospital

研究点 (1)

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