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
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
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