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临床试验/NCT06855875
NCT06855875已完成不适用

Evaluation of Autogenous Tooth- Derived Graft With Bovine Bone For Surgical Repair of Unilateral Alveolar Cleft

Tanta University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年8月10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
16
试验地点
1
主要终点
visual analogue scale

研究概览

简要总结

The aim of this study is evaluation of autogenous tooth-derived graft combined with bovine bone for surgical repair of unilateral alveolar cleft .

详细描述

Decalcified dentin graft is thought to be a good graft material that can substitute existing autogenous bone graft materials. It can be easily and readily available, with minimal risk of infection, minimal donor site morbidity as no vital bone is sacrificed, it can be easily shaped to fit into the bony defect and it can be used as block or in powder forms, the hypothesis is to evaluate the biological and the physical properties of both and autogenous tooth derived graft and bovine bone to increase the quality and density of newly formed bone in alveolar cleft grafting

Criteria of patient selection:

Inclusion Criteria:

Patients with unilateral alveolar clefts requiring repair. patients free from any systemic disease that may affect normal healing of bone. patients in an age 7y up to 14 y. patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth& non functional tooth in the study group.

Exclusion criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with unilateral alveolar clefts requiring repair.
  • •patients free from any systemic disease that may affect normal healing of bone.
  • •patients in an age 7y up to 14 y.
  • •patients have teeth to be sacrificed, as primary teeth, carious teeth, malposed teeth, supernumerary tooth& non functional tooth in the study group.

排除标准

  • •Bilateral alveolar clefts.
  • •Immunocompromized patients.
  • •Syndromic patients.
  • •Patients have good full set of teeth, cannot be sacrified in study group

研究组 & 干预措施

autogenous tooth graft combined with bovine bone

Experimental

This include 8 patients with unilateral alveolar cleft which will be repaired using autogenous tooth graft combined with bovine bone .

干预措施: autogenous tooth graft combined with bovine bone (Procedure)

bovine bone

Experimental

This include 8 patients in whom alveolar cleft will be repaired using bovine bone .

干预措施: bovine bone (Procedure)

结局指标

主要结局

visual analogue scale

时间窗: 1 month

0 representing no pain and 10 representing the highest level of pain

inflammation score scale

时间窗: 1 month

0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

次要结局

  • bone mineral density(6 months)

研究者

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

Marwa Taha Ibrahim

Ass Prof

Tanta University

研究点 (1)

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