跳至主要内容
临床试验/NCT04381585
NCT04381585Unknown不适用

Efficacy of Distraction Osteogenesis in Vertically Deficient Anterior Maxillary and Mandibular Bone by Using Mini Distractor With a Submerged Activation Component. A Clinical and Radiographical Study

SVS Institute of Dental Sciences2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
height of the residual bone

研究概览

简要总结

ADO is a bone regeneration technique, introduced by Chin and Toth in 1996 based in a biological process used for regenerate and consolidate bone between two bone segments obtained after osteotomy.These segments have been gradually separated by the process of distraction. ADO can be performed both horizontally (AHDO) and vertically (AVDO).

详细描述

Distraction osteogenesis (DO) can be used to regenerate missing hard and soft tissue, Distraction osteogenesis relies on the body's ability to generate bone as two segments of bone are "distracted" apart. The osteotomies are created and the distraction device is placed. Typically, there is a latency phase of one week were a fibrovascular bridge is formed in the osteotomy site. This provides a template to generate new bone as the segments are distracted apart during the activation phase. Once the desired distraction has occurred, the device is left in place for a period of time. Once consolidation (typically 2 to 6 months) has occurred, the distraction device can be removed and implants can be placed. Chiapasco compared GBR to DO and found that both are equally effective in alveolar bone augmentation for implant placement and further stated that the long-term prognosis of vertical bone gain in DO is more predictable.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acquired alveolar defects (Post extraction, Traumatic avulsion of teeth, Periodontal disease, After tumor resection), congenital alveolar defects, vertically deficient edentulous ridge in maxillary or mandibular anterior region with
  • Allen Type A moderate vertical ridge deficiency (3-6mm)
  • Exclusion Criteria
  • Medically compromised patients
  • Subjects who underwent radiotherapy or chemotherapy
  • Smokers and
  • Radiographic presence of less than 5mm of anterior maxillary and mandibular bone height

排除标准

  • 未提供

结局指标

主要结局

height of the residual bone

时间窗: From baseline to 6months.

In radiographs, height of the residual bone will be taken as preoperative height. The gain in height of bone will be estimated after 6-months as postoperative bone height.

次要结局

  • Degree of inflammation in gingiva(From baseline to 2-months)

研究者

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

Dr R Viswa Chandra

Primary Investigator

SVS Institute of Dental Sciences

研究点 (2)

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