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临床试验/NCT05556330
NCT05556330招募中不适用

Assessment of Horizontal Ridge Augmentation in Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique: Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年6月1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
24
试验地点
2
主要终点
Alveolar ridge horizontal bone gain

研究概览

简要总结

Assessment of horizontal ridge augmentation in anterior mandible using computer guided autogenous cortical shell technique versus free hand technique:

randomized clinical trial

详细描述

patients with deficient anterior mandible were included in this study where control group patients received free hand harvesting and fixation of cortical shells from the symphysis, while the study group patients received the same protocol using 2 patient specific guides (psg) the first guide used for safe and accurate graft harvesting with the proposed dimensions while the second guide used for shell fixation leaving the desired gap with the recipient site that was filled with a particulate mix of xeno and auto grafts .the first guide was fixed in place allowing for accurate harvesting of the cortical shell of desired dimensions from the symphysis Then; the harvested shell was fixed to the second guide outside the patients mouth using micro screws And this fixation guide was finally secured to its final position using two interlocking wings to lock into the first guide at the surgical site as a verification step for the accuracy of the whole procedure. Finally, the 2 guides were removed after shell fixation to the recipient site in a through and through manner st the proposed planed position.

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
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Age ranges from 25-55 years. No sex predilection.
  • Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
  • Edentulous anterior mandible with horizontally deficient alveolar ridge that is less than 3mm width.
  • Normal vertical dimension with normal inter-arch space.
  • The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.

排除标准

  • • Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.
  • Previous grafting procedures in the edentulous area.

结局指标

主要结局

Alveolar ridge horizontal bone gain

时间窗: one day

amount of horizontal bone gain in millimeters measured by cbct

次要结局

  • Alveolar ridge horizontal augmentation accuracy in 3D space(one day)

研究者

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

Mohamed Ibrahim Ahmed Sakr

OMFS Resident

Cairo University

研究点 (2)

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