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临床试验/NCT06304376
NCT06304376已完成不适用

Evaluation of Shell Technique for Reconstruction of Alveolar Cleft: Retrospective Study

October 6 University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Volumetric bone gain

研究概览

简要总结

This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT.

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

入选标准

  • •Patients with alveolar ridge cleft
  • •Males and females 7-14 years of age.
  • •Patients with adequate oral hygiene.
  • •Compliance with all requirements in the study and signing the informed consent.

排除标准

  • •Patients with diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes, Glycated hemoglobin- HbA1c ≥ 7%).
  • •Patients with systemic disease affecting bone healing.
  • •Patients who are chronic users of medications known to affect the periodontal status (calcium antagonists, anti-convulsives, immunosuppressives, anti-inflammatory medications).
  • •Patients with history of intravenous and/or oral bisphosphonate use.
  • •Pathologic lesions or acute infection in the area of defect.
  • •Patients with poor oral hygiene that are not amenable to motivation and improvement.
  • •8. Vulnerable patients.

研究组 & 干预措施

study group

Other

This study group contains of patient who had alveolar cleft, indicated for late secondary alveolar grafting

干预措施: Alveolar ridge grafting (Procedure)

结局指标

主要结局

Volumetric bone gain

时间窗: 4 months

bone volumetric gain and changes measured by CBCT analysis

次要结局

  • Eruption of the tooth in the cleft(6-9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khalid Tarek Mohamed Karkar

Priniciple investigator

Ministry of Health, Kuwait

研究点 (1)

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