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临床试验/NCT02583737
NCT02583737Unknown不适用

Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial

University of Sao Paulo0 个研究点目标入组 15 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
主要终点
volume of bone neoformation in mm3

研究概览

简要总结

Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region.

排除标准

  • recent sinusitis history
  • hypersensibility for sinus allergens, tabagism, ethylism
  • severe periodontal disease, diabetes, hypertension.
  • Cases that occur schneiderian membrane perforation will be excluded from the final sample.

结局指标

主要结局

volume of bone neoformation in mm3

时间窗: six months after grafting

computational software for analysis the micro CT scanning of trephine bone samples images

area of bone neoformation in μm2

时间窗: six months after grafting

IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images

次要结局

  • dental implants stability value(six months after dental implant)

研究者

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

Maria Cristina Zindel Deboni

Associate Professor

University of Sao Paulo

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