跳至主要内容
临床试验/NCT06585566
NCT06585566招募中不适用

Evaluation of Secondary Alveolar Cleft Reconstruction With Labial and Palatal Retromolar Cortical-Shells (A Case Series Study)

Beni-Suef University3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
3
主要终点
Horizontal bone width

研究概览

简要总结

The main goal of the secondary alveolar bone grafting (SABG) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements.

The study evaluates the outcomes of a ( SABG) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.

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
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft.
  • good oral hygiene and general good health

排除标准

  • The evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae.
  • Those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing.
  • A history of previous failed alveolar cleft reconstruction.

结局指标

主要结局

Horizontal bone width

时间窗: 6 months consolidation period

The amplitude of radiographic horizontal bone width change

次要结局

  • Vertical bone level(6 months consolidation period)
  • Bone density(6 months consolidation period)

研究者

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

Amr Gibaly

Associate Professor of Oral and Maxillofacial Surgery

Beni-Suef University

研究点 (3)

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