DRKS00009669已完成未知
Clinical Pilot study to investigate safety of Collagen Matrix 10808 in combination with a Coronally Advanced Flap (CAF) in the treatment of single tooth gingival recession -
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
- •1. Signed informed consent with given ample time
- •2. Age 18 years or older
- •3. Recession defects are Miller Class I-II at incisors, canines or premolars
- •4. Recession size of > 3mm
- •5. Presence of at least 1 mm keratinized tissue around the target tooth
- •6. Full-Mouth Plaque score < 25% (O'Leary, Drake et al. 1972)
- •7. Patients with healthy or effectually treated periodontal conditions
排除标准
- •1.General contraindications for dental and/or surgical treatments
- •2.Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy
- •3.Inflammatory and autoimmune disease of oral cavity
- •4.History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years
- •5.Radiotherapy of head area
- •6.Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants)
- •7.Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease)
- •8.Untreated acute periodontal disease
- •9.Smokers (zero cigarettes allowed per day)
- •10.Diabetes
- •11.Pregnant or lactating women
- •12.Women of child bearing age, not using a highly effective method of birth control
- •13.Allergy to collagen
- •14.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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