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临床试验/NCT05390996
NCT05390996Unknown不适用

Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods: A Randomized Controlled Study

University of Baghdad2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
试验地点
2
主要终点
primary stability

研究概览

简要总结

The aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after implant installation (primary stability) , 6 week after the insertion of implant and 12 weeks later (secondary stability)

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • medically fit patients ≥ 18 years of age including both genders
  • alveolar ridges of sufficient vertical and horizontal dimensions
  • bone density less than 850 Hounsfield units (HU) which corresponds to D3-D5 bone density according to Misch bone classification based on preoperative CBCT findings

排除标准

  • Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
  • Patient with severe buccal plate undercut or concavity
  • Active infection or inflammation in the implant zone
  • Presence of any uncontrolled systemic diseases.
  • Any patient need advance treatment such as sinus lifting and bone augmentation.

结局指标

主要结局

primary stability

时间窗: 0 day (baseline)

Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

secondary stability

时间窗: 12 week post surgery

Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

stability at the dip period

时间窗: 6 week post surgery

Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100

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

Noor Abdulhakeem

Msc.student

University of Baghdad

研究点 (2)

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