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临床试验/DRKS00006005
DRKS00006005已完成未知

A pilot study to investigate safety and effectiveness of Collagen Matrix 10808 to increase soft tissue thickness simultaneous to GBR and implant placement

Geistlich Pharma AG0 个研究点目标入组 10 人开始时间: 2014年3月21日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
10

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
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Patients will be included in the study if they present all of the following conditions:
  • Signed informed consent
  • Age 18 years or older
  • Absence of significant medical conditions
  • Patients with healthy or effectually treated periodontal conditions
  • Full-Mouth Plaque score less than 25% (O’Leary et al. 1972)
  • Candidate for single tooth replacement in the anterior maxilla
  • Implant sites with the need for contour augmentation using GBR (Chen & Buser 2009)
  • Implant sites which allow the concept of early implant placement after tooth extraction

排除标准

  • Patients will not be included in the study if they present one of the following conditions:
  • General contraindications for dental and/or surgical treatments
  • Immunosuppressant, corticosteroid or bisphosphonate therapy
  • Inflammatory or autoimmune disease of oral cavity
  • History of malignancy, radiotherapy or chemotherapy for malignancy within the past five years.
  • Uncontrolled diabetes
  • Pregnant or lactating women
  • Women of child bearing age, not using a standard accepted method of birth control
  • Allergy to collagen
  • Participation in an investigational device, drug or biologic study within the last 24 weeks prior to the study start

研究者

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