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临床试验/NCT01572298
NCT01572298已完成不适用

A Prospective Study: Alveolar Ridge Augmentation Using Tenting Screws, Acellular Dermal Matrix and Combination Particulate Grafts.

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Gain in Horizontal Ridge Dimension

研究概览

简要总结

When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).

详细描述

Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subject with a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and inadequate buccolingual dimension for dental implant placement as measured clinically and radiographically
  • live within "catchment area" of 50 mile radius from San Antonio

排除标准

  • unstable systemic disease (such as compromised immune system)
  • patient taking steroids or other medications affecting bone metabolism
  • patient with history of radiation therapy to head & neck
  • history of previous ridge augmentation procedure or pathology at local jaw site
  • smokers who smoke > 10 cigarettes per day

研究组 & 干预措施

allograft with autograft

Experimental

guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)

干预措施: allograft with autograft (Device)

allograft alone

Active Comparator

guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)

干预措施: allograft alone (Device)

结局指标

主要结局

Gain in Horizontal Ridge Dimension

时间窗: 5 months after surgery

次要结局

  • Percentage of New Bone Formation (Histologic)(5 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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