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临床试验/NCT04693741
NCT04693741Unknown不适用

Xenografts With Platelet-rich Fibrin Versus Autogenous Bone in Alveolar Cleft Grafting: A Comparative Clinical Study

Assiut University0 个研究点目标入组 36 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
主要终点
measuring of bone volume 6 months post-operative.

研究概览

简要总结

this work aims to evaluate xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting.

详细描述

The alveolar cleft is a maxillary bone defect resulting from incomplete fusion of the medial nasal process (MNP) and maxillary process (MXP) during embryonic development. Alveoloplasty may be classified as primary, secondary, and tertiary depending on the age of the patient. Literature defines primary when the alveoloplasty is performed at the same time as soft tissue repair. If performed at the age of 8 to 9 years before the eruption of the permanent canine, it is classified as secondary; it is classified as late secondary or tertiary if performed in the elderly. For patients with cleft lip and palate, secondary alveolar bone grafting (SABG) of the cleft alveolar ridge is performed when the patient has mixed dentition; SABG is a procedure that aims to create a bony bridge that restores dental arch continuity, repair the oronasal fistula, provide support to the structure of the alar base, facilitate subsequent orthodontic treatment, and promote tooth eruption. Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest bone being the most widely accepted donor site. Other materials such as growth factors, combinations of improved scaffolds and cell treatment/growth factors, biocomposites, and hemostatic agents can be used to regenerate bone and have been the subjects of intensive research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age (7 - 12 years).
  • Non-syndromic CLA or CLP.
  • More than 6 months of follow-up.

排除标准

  • History of previous alveolar surgery.
  • History of active infection or underlying diseases such as hematologic disorders, neoplasm, and immune deficiency
  • Patients who had received primary or tertiary ABG.

结局指标

主要结局

measuring of bone volume 6 months post-operative.

时间窗: 6 months

Compare between outcome of xenografts mixed with PRF versus autogenous bone graft in alveolar cleft grafting regarding the newly formed bone volume.

次要结局

未报告次要终点

研究者

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

Hager Montaser Sayed Bedeer

MBBS

Assiut University

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