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临床试验/NCT02349620
NCT02349620Unknown2 期

Platelet-rich Factot in Implant Dentistry

Reza Tabrizi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
30
试验地点
1
主要终点
implant loss

研究概览

简要总结

The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.

详细描述

Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial & distal side on standardized IOPA x-rays.

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, Investigator)

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

入选标准

  • patients who have 1 or 2 missing teeth in both side of posterior mandible
  • adequate bone quantity and quality at the implant site
  • the implant sites with at least 3 months of healing after extraction,
  • patients well motivated for implant therapy and maintaining good oral hygiene
  • the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm.
  • Patients who gave written informed consent

排除标准

  • • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome
  • infection around the implant site
  • history of bruxism/parafunctional habits
  • patients with history of any bleeding disorder or on anti-coagulant therapy.
  • pregnant patients

结局指标

主要结局

implant loss

时间窗: 6 months

During the osseointegration, if the implant lose his stability and if the patient have pain, the implant will be removed and the implant will be considered lost

次要结局

  • ISQ analysis(3 months)
  • bone height (mm)(6 months)

研究者

发起方
Reza Tabrizi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reza Tabrizi

Assistant professor of shahid beheshti university of medical sciences

Shiraz University of Medical Sciences

研究点 (1)

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