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临床试验/NCT05941988
NCT05941988已完成不适用

The Effect of Pre Grafting Partial Maxillary Expansion With Post Grafting Expansion Versus Pre Grafting Full Maxillary Expansion on the Stability and Bone Resorption in Secondary Unilateral Alveolar Cleft Grafting

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月20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
20
试验地点
1
主要终点
Bone volume change

研究概览

简要总结

Intermediate grafting with both pre- and post- grafting maxillary expansion with time span after grafting 6-8 weeks for consolidation and final retention for 3 months after finalization of expansion will get the advantages of both techniques combined.

详细描述

Secondary alveolar bone grafting (SABG) is an essential step in the overall management of Patients with cleft lip and palate (CLP). The numerous advantages of this procedure have been reported in the literature. However, resorption of the bone graft is a common situation, and the success of alveolar bone grafting (ABG) depends on several factors . The periodontal health of the surrounding graft tissues, the experience and ability of the surgeon and the timing of surgery are shown to be the most important factors determining success. Failure to rehabilitate the alveolar cleft may give rise to a variety of problems, including oronasal fistula, fluid reflux, speech pathology, impaired tooth eruption, lack of bone support for the anterior teeth, dental crowding, periodontal recession and eventual loss of teeth, and maxillary and facial asymmetry . Lack of alveolar bone also limits orthodontic treatment and/or prosthodontics rehabilitation. Post graft stimulation of maturation through remodeling of the graft is extremely important and is provided primarily by natural tooth eruption. Thus, the ideal time period for SABG is shown as to be the mixed dentition stage (9-12 years), just before the eruption of the permanent canine in line with the cleft. Timing of maxillary expansion in patients with cleft lip and palate is debated. Proponents of expanding the maxilla prior to secondary alveolar bone grafting state it is beneficial to align the segments prior to bone grafting better access for placement of the graft and working facility during surgery, However more recent literature shows maxillary expansion after secondary bone grafting is possible Advocates of expansion following grafting cite the advantages that bone consolidation is improved when the graft is placed under a dynamic load during healing and that there is a smaller soft tissue defect to close, less difficulty procuring an adequate volume of bone, and a narrower defect, which will regenerate bone more quickly and less possibility to induce oronasal fistula during maxillary expansion the study will change the concept of alveolar bone grafting in relation to maxillary expansion .just getting 5 mm minimal between two cleft edges and 2/3 of canine or lateral root has been formed and thin bone separate tooth from cleft defect the graft could be done

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with unilateral cleft alveolus with in the mixed dentition stage No intraoral soft and hard tissue pathology No systemic condition that contraindicate grafting

排除标准

  • •Local criteria:
  • •poor oral hygiene
  • •radiation therapy the head and neck cancers
  • •Systemic criteria:
  • •immunity deficiency or hemorrhagic inherited diseases
  • •Bone pathology

研究组 & 干预措施

pre grafting partial maxillary expansion with post grafting expansion

Experimental

pregrafting partial maxillary expansion then grafting left bone to consolidate for 2 months followed by post grafting expansion till full arch alignment

干预措施: pre grafting partial maxillary expansion with post grafting expansion (Procedure)

pre grafting full maxillary expansion

Active Comparator

pre grafting full maxillary expansion till full arch alignment then grafting and let bone to consolidate

干预措施: pre grafting partial maxillary expansion with post grafting expansion (Procedure)

结局指标

主要结局

Bone volume change

时间窗: 6 months

bone volume is measured to ensure successful grafting

次要结局

  • presence of relapse of expansion(8 months)

研究者

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

mohamed fakhry

resident at oral and maxillofacial surgery department

Cairo University

研究点 (1)

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