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Tooth-borne Interdental Distraction Osteogenesis Along Arch Curvature for Wide Alveolar Clefts Reduction (IDO)

2026年5月5日 更新者:Ain Shams University

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Cairo、埃及、11566
        • Department of Orthodontics, Faculty of Dentistry, Ain Shams University Cairo, Abbaseya, Egypt

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Tooth borne interdental distraction along arch curvature appliance
Patients eligible to the study were prepared to receive interdental distraction osteogenesis. The appliance was custom made for each patient. It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment .

This study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport.

After cases' selection, arch expansion was done first.

Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy.

Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment.

The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily.

Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period.

其他名称:
  • Tooth borne alveolar distractor
  • Buccal mini hyrax distractor

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Reduction of width of alveolar cleft and oronasal fistula
大体时间:2-3 months
Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph
2-3 months

次要结果测量

结果测量
措施说明
大体时间
Dental changes with distraction
大体时间:2-3 months
Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph
2-3 months
Quality of distracted bone
大体时间:3-6 months
Measurement of bone radio density in Hounsfield Unit from CBCT
3-6 months
Loss of anchorage with distraction forces
大体时间:2-3 months
Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph
2-3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月15日

初级完成 (实际的)

2021年12月12日

研究完成 (实际的)

2022年1月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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