跳至主要内容
临床试验/NCT03680118
NCT03680118Unknown不适用

Vertical Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Guided Bone Regeneration Using Collagen Membrane Versus Autogenous Bone Graft Only Using Titanium Mesh in Atrophic Posterior Mandibles.

Cairo University0 个研究点目标入组 24 人开始时间: 2018年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
vertical bone gain

研究概览

简要总结

Atrophic ridge augmentation utilizing guided bone regeneration (GBR) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. GBR was initially employed to treat simple defects, including dehiscence and fenestration defects. In addition, GBR has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. The results of recent clinical and histologic studies of ridge augmentation with GBR indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. The main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. Because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration

详细描述

The GBR Procedure requires to place a barrier between the bone graft and the surrounding soft tissues. This blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site.

Collagen membranes have been successfully used as a barrier membrane in clinical practice.

They have the advantage of being resorbable and pose less post-operative complications. On the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge.

Alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. They provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect.

However they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients with edentulous posterior mandible.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.
  • Residual alveolar bone height more than 6 mm (7-9 mm) and less than 12 mm.

排除标准

  • Presence of fenestrations or dehiscence of the residual ridge.
  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

研究组 & 干预措施

autogenous rings with GBR and autogenous graft with ti-mesh

Experimental

Augmentation with autogenous onlay ring blocks covered by guided bone regeneration (GBR) using collagen membrane and autogenous bone graft using titanium mesh (ti-mesh) only

干预措施: autogenous rings with GBR and autogenous graft with ti-mesh (Device)

结局指标

主要结局

vertical bone gain

时间窗: 6 month

the amount of vertical bone gain will be measured using cone beam computed tomography

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

Mostafa Shawky Abd El-Moneim Shaheen

principal investigator

Cairo University

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