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临床试验/NCT03613415
NCT03613415Unknown不适用

Evaluation of Implant's Primary Stability Using Densah Bur Versus Expander in Patients With Missing Maxillary Premolar (A Randomized Clinical Trial)

Cairo University0 个研究点目标入组 20 人开始时间: 2018年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
主要终点
implant's primary stability

研究概览

简要总结

evaluating use of Densah bur in thin ridge enhance implant's primary stability when compared to screw expander.

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)

盲法说明

  • Each patient will be given a code by the researcher (T.A.) and the observers will be blind to which group this case belong.
  • Patients, evaluators and statistician will be blinded.

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with partial edentulous maxillary premolar area with crestal thickness ranging from 4 to 6 mm.
  • Age 25 - 50 years.
  • No intraoral soft tissue or hard tissue pathosis.
  • No systemic condition contraindicating implant placement.

排除标准

  • Ridges thickness less than 4 mm.
  • Coexisting vertical defect.
  • Heavy smokers (more than 20 cigarettes per day).
  • Patients with systemic disease that may affect normal healing.
  • Patient with psychiatric problems.
  • History of radiation therapy to the head and neck region.

研究组 & 干预措施

Expansion by Densah bur

Experimental
  • Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient.
  • A mid crestal flap will be reflected.
  • For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth.
  • Sequential use of Densah bur under copious irrigation.
  • An implant of 3.9*10 mm will be inserted.
  • Smart peg will be placed on implant and Osstell will be used to record ISQ.
  • Healing collars will be placed on implants.
  • Flap will be prepared for closure and suturing.

干预措施: Expansion (Other)

Expander

Active Comparator

Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient.

  • A mid crestal flap will be reflected.
  • For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth.
  • Sequential use of screw expanders.
  • An implant of 3.9*10 mm will be inserted.
  • Smart peg will be placed on implant and Osstell will be used to record ISQ.
  • Healing collars will be placed on implants.
  • Flap will be prepared for closure and suturing.

干预措施: Expansion (Other)

结局指标

主要结局

implant's primary stability

时间窗: Implant stability will be measured at eighth week

Implant stability will be measured by Ostell device.

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

Ahmed Hisham Mahmoud Riad

Principal Investigator (doctor)

Cairo University

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