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临床试验/NCT06691516
NCT06691516尚未招募不适用

Radiographic Assessment Of The Accuracy Of 3D Ridge Augmentation In Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique

Cairo University0 个研究点目标入组 22 人开始时间: 2024年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
22
主要终点
accuracy of the implanted bone blocks

研究概览

简要总结

* this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol.

the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement

  • also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
  • also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
  • also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.

详细描述

this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol.

the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement

  • also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
  • also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
  • also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ranges from 20-60 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 a horizontally deficient alveolar ridge that is less than 3mm in width and with a vertically defect at least 3mm in height.
  • •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

研究组 & 干预措施

computer guide cortical shell technique in anterior mandible 3d defect

Experimental

in study group there are bone harvesting guide and two fixation guides

干预措施: horizontal and vertical bone augmentation using computer guided cortical shell technique (Procedure)

free hand cortical shell technique in anterior 3d defect

Active Comparator

in control group, the bone harvesting and shells fixation will done with free hand technique

干预措施: free hand cortical shell technique in anterior 3d defect (Procedure)

结局指标

主要结局

accuracy of the implanted bone blocks

时间窗: immediately post operative

* depening on the superimposition between immediate postoperative CBCT scan over planning * the maximum thickness of the implanted bone blocks (mimics)

次要结局

  • bone gain vertical and horizontal(6 months)

研究者

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

Ahmed Salah Sayed Ibrahim Elballal

Dr.Ahmed Salah

Cairo University

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