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临床试验/NCT02332421
NCT02332421已完成不适用

A Comparison Of The Short-Term Therapeutic Effects Between Two Distractors Used For The Retraction Of Maxillary Canines By Dentoalveolar Distraction Osteogenesis

Damascus University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Change in the mesiodistal inclination of the canine

研究概览

简要总结

In this study, two distractors will be used to retract maxillary canines into the extraction sites. The first distractor is a modified Hyrax expander with two arms soldered to two bands connected to a canine and a molar; and the second one is a similar to the first one but with the addition of a third arm.

The purpose of this investigation is to compare the two distractors in terms of: final position of the canine, canine pulp vitality, molars' anchorage, patient's acceptance to the appliance.

详细描述

The retraction of the canines is one of the longest and most important stages in the orthodontic treatment of cases that require premolars extraction. The retraction phase of the canines into an extraction site with conventional treatment method usually lasts about 4 to 6 months under normal circumstances. The use of dentoalveolar distraction (DAD) technique has been considered a very important step in this field. It has been shown by early case reports that this technique can be employed to retract canines within 10 to 14 days.

Although DAD is thought to accelerate tooth movement during canine retraction, a significant amount of tipping (distal tilting) was observed in many case reports. So in this study, there is an intention to apply a modified DAD device on one side of the mouth and to compare it with the conventional one applied on the opposite side of the mouth in each participating patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for extraction of upper first premolar and conducting canine retraction
  • Good oral hygiene

排除标准

  • Buccal or palatal inclination of the canines
  • Mesial or distal inclination of the canines
  • Contraindication to minor surgery
  • Previous orthodontic or surgical treatment
  • Root canal treatment to the canines
  • Malformation of the canines

结局指标

主要结局

Change in the mesiodistal inclination of the canine

时间窗: This will be measured at three times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.

This will be measured using a lateral cephalogram taken at these assessment times. The long axis of the canine will be drawn on the tracing of the cephalogram at each assessment time and this long axis will be measured with reference to anterior cranial base.

次要结局

  • Change in Canine Pulp Vitality(This will be measured at three times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.)
  • Molars Anchorage Loss(Upper first molar position will be measured at three assessment times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.)
  • Patient acceptance to each distractor(This is going to be measured at: (T1) first day following surgery, (T2) five days following surgery, (T3) two weeks following surgery, and (T4) at the time of appliance removal.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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