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临床试验/NCT07054658
NCT07054658已完成不适用

Evaluation of Allogenic Bone Ring Graft With Simultaneous Implant Placement for Vertical Ridge Augmentation

Tanta University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月23日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Vertical Bone Gain in mm

研究概览

简要总结

This clinical trial aimed to evaluate the effectiveness of vertical ridge augmentation using customized allogenic bone ring grafts with simultaneous dental implant placement in the posterior mandible. The procedure is designed to address vertical bone deficiencies without the need for autogenous bone harvesting, thereby reducing patient morbidity and surgical complexity. The study assessed clinical outcomes including bone gain, implant stability, and over a 6-month period and inflammation, infection, pain and neurosensory changes where assessed for 4 weeks.

详细描述

This study investigated the clinical outcomes of vertical ridge augmentation using allogenic bone rings in combination with simultaneous implant placement for the treatment of posterior mandibular bone defects. Traditional ridge augmentation techniques often require two-stage surgeries and autogenous bone harvesting, which may increase patient morbidity and prolong healing. In contrast, the allogenic bone ring technique provides a one-stage approach by allowing vertical augmentation and implant placement to be performed simultaneously.

The study was designed as a prospective, single-arm clinical trial. Eligible patients aged 18 years or older, presenting with vertical bone deficiencies in the posterior mandible, were recruited from the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. The primary outcome was vertical bone gain measured radiographically at 6 months postoperatively. Secondary outcomes included implant stability (measured by IST), soft tissue healing, and postoperative complications. Patients were followed clinically and radiographically to evaluate the success of the grafting procedure and implant integration.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with vertical alveolar ridge atrophy in the posterior mandible who are motivated, cooperative, and have good oral hygiene.
  • Minimum of 7 mm remaining bone height from the crest of the alveolar ridge to the inferior alveolar canal.
  • Patients with adequate remaining interarch space

排除标准

  • Prior local radiation therapy.
  • Soft and hard tissue pathology at the operation site.
  • Systemic diseases that might affect bone healing and osseointegration (e.g., uncontrolled diabetes)..
  • smokers who consume 20 or more cigarettes per day.
  • patients on anti-resorptive drugs (eg: bisphosphonates and denosumab).

结局指标

主要结局

Vertical Bone Gain in mm

时间窗: 6 months postoperatively

The vertical bone gain was measured radiographically using CBCT imaging to evaluate the effectiveness of the allogenic bone ring graft in augmenting vertical bone height in the posterior mandible

次要结局

未报告次要终点

研究者

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

Ibrahim Taha Hussein

Principal Investigator

Tanta University

研究点 (2)

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