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临床试验/NCT02865590
NCT02865590已完成不适用

Clinical and Histological Evaluation of Demineralized Bone Allograft and Lyophilized Equine Bone Allograft for Sinus Lift: Double Blind, Parallel, Randomized Clinical Trial.

University of L'Aquila0 个研究点目标入组 16 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
主要终点
Histomorphometric Evaluation of New Bone Formation.

研究概览

简要总结

The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • bilateral atrophy of the maxilla;
  • bone ridge <= 6mm

排除标准

  • severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3 years history of radiation therapy to neck and head area sinusitis pregnancy subjects not able to consent to participate in the study.

结局指标

主要结局

Histomorphometric Evaluation of New Bone Formation.

时间窗: 6 months

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

Enrico Marchetti

assistant professor

University of L'Aquila

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