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临床试验/NCT02711111
NCT02711111Unknown不适用

Effect of Bone-anchored Protraction on Maxillary Growth in the Young Child

Ziekenhuis Oost-Limburg1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis

研究概览

简要总结

Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age. To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage.

详细描述

Rationale:

Class III malocclusions may originate in a retrognathic maxilla, a prognathic mandible or both. Young patients with class III malocclusion and maxillary hypoplasia are conventionally treated with a protraction facemask or reverse twin block appliance in order to stimulate forward growth of the upper jaw. This treatment option is often inducing unwanted side effects including mesial migration of the teeth in the upper jaw and clockwise rotation of the mandible. Because skeletal effects are often difficult to achieve with this approach, more pronounced class III malocclusions cannot be addressed by face mask therapy. These children cannot be treated during childhood and end up in major orthognathic surgery at full-grown age.

To be able to treat also the more pronounced class III malocclusion and to minimize dentoalveolar compensations new treatment methods were developed which uses skeletal anchorage. In maxillary deficiency cases it's common to have the deficiency anteroposteriorly as well as transversely. Opening of the midpalatal suture by rapid expansion can correct the transverse hypoplasia and may produce more anterior movement of the maxilla. The proposed technique enables to start skeletal anchorage treatment at an earlier age, which also has the potential of more growth modification during treatment.

Objective:

To compare a new technique of skeletal traction with incorporation of maxillary expansion to conventional treatment protocols.

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
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •healthy subjects 7 - 14 years old Class III occlusion maxillary hypoplasia good oral hygiene no craniofacial syndrome

排除标准

  • 未提供

研究组 & 干预措施

orthodontic bone anchor

Experimental

new bone anchor device, which creates anterior traction on the upper jaw. Placed on the chin-region intra-orally.

干预措施: orthodontic bone anchor (Device)

face mask protraction

Active Comparator

control group, conventional treatment method. Face mask creates anterior traction on the upper jaw

干预措施: Face mask (Device)

结局指标

主要结局

effect of bone-anchored protraction on maxillary growth in the young child, 1 year with 3D analysis

时间窗: 1 year

assessment of anterior growth of the upper jaw, 1 year after start of treatment

effect of bone-anchored protraction on maxillary growth in the young child, 5 years, with 3D analysis

时间窗: 5 years

assessment of anterior growth of the upper jaw, 5 years after start of treatment

次要结局

  • complications registration(1 year)
  • patient satisfaction(1 year)

研究者

发起方
Ziekenhuis Oost-Limburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joeri Meyns

J. Meyns, M.D., D.M.D., oral and maxillofacial Surgery, principal investigator

Ziekenhuis Oost-Limburg

研究点 (1)

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