Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- We measure space extraction close after 8 months treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account.
研究概览
简要总结
The main objective of the investigators' study is to assess the efficacy of a course of treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental anchorage (reference) during dentofacial orthopedic treatment.
详细描述
Multicenter prospective study on patients aged between 12 and 50 years, requiring orthodontic treatment with premolar extractions and closure of the extraction spaces by distalization of the 6 anterior teeth. In the experimental group (50 patients) distalization will be performed using skeletal anchorage (MINISCREW). In the control group (50 patients), distalization will be by dental anchorage.
The main evaluation criterion will be extraction space closure after 8 months of treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account. Evaluations will be made by very precise radiological analysis using 3D CT-scan. Examinations will be done before and after closure of the extraction sites and will assess treatment efficacy using skeletal anchorage versus dental anchorage. Patients will also be requested to complete a satisfaction questionnaire. The study will comprise an inclusion appointment during which patient consent will be obtained and a regular monthly appointment during the 8 months of active treatment and space closure.
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
- None
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 12 to 50 years old
- •Patient need orthodontic treatment with extraction of 2 maxillary bicuspid
- •Patient has signed informed consent
排除标准
- •Patient younger than 12 and older than 50 years old
- •Patient without social security affiliation
- •Patient with a medical condition that indicates against orthodontic treatment
研究组 & 干预措施
MINISCREW
device
干预措施: Skeletal anchorage (MINISCREW) (Device)
Reference
dental anchorage
干预措施: dental anchorage (Device)
结局指标
主要结局
We measure space extraction close after 8 months treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account.
时间窗: 8 months
次要结局
- Anchorage teeth stability(8 months)
- MINISCREW stability(8 months)
- Success and Failure implantation percentage(8 months)
- MINISCREW surgery difficulty(during the surgery act)
- Patient satisfaction(at 1 month and at 8 months)