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临床试验/ACTRN12615000027516
ACTRN12615000027516已完成未知

Single-centre, open-label, pilot study of Celgro(tm) collagen membrane for guided bone regeneration around exposed dental implants in patients undergoing dental implant surgery

Orthocell Ltd0 个研究点目标入组 20 人开始时间: 2015年1月19日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
Orthocell Ltd
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • Participant requires one or more dental implants with simultaneous bone augmentation procedure
  • - Tooth extraction procedure was performed prior to simultaneous augmentation procedure with no complications
  • - Female participants of child-bearing potential must:
  • *Have a negative pregnancy test within 72 hours of visit 1
  • *Agree not to fall pregnant while on the study
  • - Non-smoker
  • - Able to comply with the requirements of the protocol, including post-operative oral hygiene and attendance for follow-up procedures
  • - Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP

排除标准

  • - Insulin-dependent, uncontrolled or poorly-controlled diabetes mellitus
  • - History of malignancy, radiotherapy or chemotherapy within the last 5 years
  • - Female participant who is pregnant or lactating
  • - Participant is taking medication that may have an effect on bone turnover or mucosal healing
  • - General contraindications for dental and/or surgical treatment
  • - Concurrent disease or medical condition which affects bone or connective tissue metabolism
  • - Known hypersensitivity to collagen
  • - Known substance abuse
  • - Participation in another study with an investigational product within previous 3 months
  • - Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the investigator, compromise the safety or the participant or the outcome of the study

研究者

发起方
Orthocell Ltd

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