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临床试验/NCT04609475
NCT04609475已完成不适用

Osseodensification Versus Motor-Driven Expanders' Techniques for Increasing Bone Density With Simultaneous Implant Placement (Randomized Controlled Clinical Trial)

Nourhan M.Aly1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年10月14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
发起方
入组人数
14
试验地点
1
主要终点
Implant stability

研究概览

简要总结

The aim of this study was to compare and measure the amount of bone density and ridge width gained with motor driven expanders and densifying burs with simultaneous dental implant placement.

详细描述

Seven patients were treated by the osseodensification technique and another seven were treated by the motor-driven expanders' technique with simultaneous implant placement.

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
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients requiring implant placement in the anterior maxilla until the premolar region.
  • •Patients are medically fit.
  • •The width of the deficient maxillary alveolar ridge not less than 3mm.
  • •Patients willing and fully capable to comply with the study protocol.

排除标准

  • •Atrophic ridge (2 mm or less) with no interposition of cancellous bone between the buccal and palatal plates.
  • •Uncontrolled metabolic disease (e.g. uncontrolled diabetes).
  • •Heavy smokers (>15 cigarettes/day).
  • •Acute oral infections.
  • •Untreated periodontal disease.
  • •Poor oral hygiene.
  • •Pregnant or breastfeeding patient.
  • •A history of radiotherapy to the head and neck region or treatment with bisphosphonates.
  • •Female patients using oral contraceptive pills.
  • •Presence of oral parafunctional habits.
  • •Surgical site needs to be grafted.

研究组 & 干预措施

Osseodensification technique

Experimental

干预措施: Osseodensification technique (Procedure)

Motor driven expanders' technique

Active Comparator

干预措施: Motor driven expanders' technique (Procedure)

结局指标

主要结局

Implant stability

时间窗: up to 6 months

Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded.

Bone density

时间窗: up to 6 months

This will be assessed using cone beam computed tomography (CBCT)

Post-operative pain

时间窗: up to 1 month

Pain was assessed using a 10-point Visual Analogue Scale (VAS). The lower values indicates lower pain levels and higher values indicates higher pain levels

次要结局

未报告次要终点

研究者

发起方
Nourhan M.Aly
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

University of Alexandria

研究点 (1)

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