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临床试验/NCT05362136
NCT05362136招募中不适用

Assessment of the Effect of Sinus Floor Perforation During Sinus Floor Elevation on Bone Formation Within the Augmentation Material

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
12
试验地点
1
主要终点
New bone formation

研究概览

简要总结

The aim of the present study is to compare the rate of new bone formation after sinus floor elevation with or without perforation of the cortical sinus floor prior to insertion of augmentation material. Twelve patients requiring bilateral sinus floor elevation will be recruited for a pilot study in split-mouth design. On both sides a lateral window will be prepared and the sinus mucosa will be elevated. After this step, the sides are assigned as test or control side. While the control side is just filled with augmentation material, an additional step is performed for the test side, i.e., prior to inserting the augmentation material, the cortical bone layer of the sinus floor is perforated several times into the trabecular bone layer to improve the blood supply to the grafting material. Thereafter, both sides are left to healing for 4-6 months until implant installation. At timepoint of implant installation, a bone biopsy will be collected to allow histological assessment of the grafted area.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •in need of bilateral sinus floor elevation
  • •residual alveolar ridge height 2-6mm
  • •residual alveolar ridge width > 4mm

排除标准

  • •uncontrolled periodontal disease
  • •acute or chronic sinusitis

研究组 & 干预措施

Control

Active Comparator

standard sinus floor elevation

干预措施: no perforation of the sinus floor (Procedure)

Test

Experimental

standard sinus floor elevation with additional perforation of the sinus floor

干预措施: perforation of the sinus floor (Procedure)

结局指标

主要结局

New bone formation

时间窗: 4-6 months after sinus floor elevation

histological assessment of new bone formation after sinus floor elevation (%)

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

Kristina Bertl

Principal Investigator

Medical University of Vienna

研究点 (1)

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