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临床试验/NCT07578207
NCT07578207已完成不适用

A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts

Ain Shams University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1

研究概览

简要总结

This clinical study provided a modified simple and small appliance for reduction of wide alveolar clefts in cleft lip and palate patients, making the grafting procedure of better prognosis and increase its success rate.

详细描述

Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.

Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.

The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.

研究设计

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

入排标准

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

入选标准

  • Patients with ages ranging from 12 to 25 years old
  • Patients with repaired cleft lip and / or palate.
  • Patients with wide alveolar clefts more than 6 mm.
  • Patients with median facial clefts, absent premaxilla.
  • Patients who had previous failed grafting.

排除标准

  • Patients with contraindications to general anaesthesia and surgery.
  • Patients with syndromic cleft lip and palate.
  • Patients with very bad oral hygiene.
  • Vulnerable groups.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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