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临床试验/EUCTR2019-001167-75-ES
EUCTR2019-001167-75-ES进行中(未招募)1 期

Randomized Clinical Trial, conventional treatment-controlled, studying the efficacy of Plasma Rich in Growth Factor (PRGF®) in alveolar ridge preservation after simple exodontia in the anterior region of maxilla.

BTI I MAS D0 个研究点目标入组 62 人开始时间: 2019年6月11日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
62

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • - Subjects of both sexes with an age greater than or equal to 18 years.
  • - Clinical indication for a simple exodontia of a uniradicular tooth in the superior maxilla
  • - Availability to follow-up during the treatment period
  • - Subjects with non-active periodontal disease.
  • - Buccal dehiscence < than 25% in the vestibular table
  • - Signing the informed content
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 56
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6

排除标准

  • Presence of an active infection
  • - Loss of any plate of the socket
  • - Severe inflammation in the area of the exodontia previous to the intervention
  • - Suffer any severe hematologic disease o disorder
  • - Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
  • - Regular treatment with AINES or other antiinflammatory drugs
  • - Previous history of chronic hepatitis or heatic cirrhosis
  • - Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
  • - Subjects submitted to hemodyalisis
  • - Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
  • - Previous history of ischemic cardiopathy in the last year.
  • - Pregnancy or womens in childbearing age who do not take contraception measures.
  • - Nursing womens
  • - Metabolic bone disease
  • - Ongoing treatment with biphosphonates both through oral or intravenous administration
  • - Smoking habits (> 10 cigarrettes/day)
  • - In general, any disability to participate in the study

研究者

发起方
BTI I MAS D

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