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临床试验/NCT05988086
NCT05988086已完成不适用

Evaluation of Using Platelet Rich Fibrin Versus Collagen Membrane for Enhancing Healing of Secondary Grafted Alveolar Cleft

Tanta University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
inflammation score scale

研究概览

简要总结

The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using autologous platelets rich fibrin versus collagen membrane for nasal layer closure in secondary alveolar cleft repair.

详细描述

Patients and methods: Twenty-four patients with alveolar clefts will be included in this study. The patients will be evaluated with age ranging between (7 - 12) years. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

The selected children should possess the following criteria: Their permanent canines either not or partially erupted, has no systemic disorder which can affect the grafting outcome and healing process such as juvenile diabetes mellitus, kidney, liver, or blood diseases and has no associated craniofacial syndromes. The patients will be classified into two groups according to incorporation of autologous platelet rich fibrin or collagen membrane for nasal layer closure with the grafting material, as follow: Group 1: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using autologous platelet rich fibrin with autogenous chin bone. Group 2: This will include 12 children in whom nasal layer of alveolar cleft will be repaired using collagen membrane with autogenous chin bone.

Preoperative evaluation of alveolar cleft site:

all patients will be examined clinically and radiologically. Clinical examination: This will consider the stability of maxillary segments, presence of old scar, asymmetry of the alar base, presence of oronasal fistula, and the presence of erupting teeth in the cleft.

Radiological examination: Panoramic radiographs will be done for each patient and examined as regard: the morphology of the cleft area, the size of the cleft side, the presence or absence of permanent lateral incisor and canine, the development of root length, and stage of eruption of permanent canine and lateral incisor. In addition, Axial computed tomography (CT) scans will be done for each patient to assess and measure local bone mineral density of grafted alveolar bone cleft.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients with unilateral alveolar cleft
  • the patient's permenant canines either not or partially erupted
  • medically free patients

排除标准

  • patients with bilateral alveolar cleft
  • medically compromised patients
  • Any associated craniofacial syndromes.

结局指标

主要结局

inflammation score scale

时间窗: 1 month

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

density of bone

时间窗: 1 month

density of bone to measure (D1,D2,D3,D4) Frome 150HU to 1250HU

visual analogue scale

时间窗: 1 month

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

次要结局

  • bone mineral density.(9 months)

研究者

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

Marwa Taha Ibrahim

lecturer

Tanta University

研究点 (2)

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