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临床试验/NCT03357068
NCT03357068已完成不适用

Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans: Qualitative, Quantitative and Immunohistochemical Analysis

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年7月1日最近更新:
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
10
试验地点
1
主要终点
Clinical bone block consolidation

研究概览

简要总结

This study evaluates the effect of citric acid demineralization in autogenous bone blocks consolidation. Half of participants will receive citric acid treatment at the bone block and recipient site. Other half will receive no demineralization treatment.

详细描述

Autogenous bone grafts are indicated in areas where there is not enough bone height and/or width for implant installation. Treatment of bone surfaces with citric acid, promote a slight demineralization on surface that mimic natural processes of bone demineralization by osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block consolidation to its recipient site.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presence of atrophic anterior maxilla (width 1.5 to 4 mm)
  • •Absence of active periodontal disease.
  • •Enough bone width on donor sites (oblique line or ment)

排除标准

  • •Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation
  • •Pregnant women
  • •Patients receiving radiotherapy or chemotherapy
  • •Patients using bisphosphonates

研究组 & 干预措施

Control

Active Comparator

Autogenous bone block surgery without treatment of bone surfaces.

干预措施: Control (Procedure)

Acid

Experimental

Autogenous bone block surgery with citric acid treatment of bone block and recipient site

干预措施: Acid (Procedure)

结局指标

主要结局

Clinical bone block consolidation

时间窗: 5 months

Absence of fibrous tissue by clinical observation

Computerized tomography images bone block consolidation

时间窗: 5 months

Absence of images compatible to fibrosis in cone beam computerized tomography images

Histological bone block consolidation

时间窗: 5 months

Absence of fibrous tissue between bone block and recipient site in histological images.

次要结局

  • Bone width(5 months)

研究者

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

Carla Andreotti Damante

Associate professor

University of Sao Paulo

研究点 (1)

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