NL-OMON51137撤回不适用
Intra-articular injection of adipose-derived stromal vascular fraction in osteoarthritis of the temporomandibular joint - SVF injection in the TMJ
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •* Age between 18-70 years
- •* Chronic nociceptive pain in the TMJ region, aggravated by protrusion, maximal
- •mouth opening, lateral excursions and/or chewing of at least 2 months
- •* Wilkes stages III or IV (internal derangement)
- •* Limited maximal interincisal opening (< 35 mm and > 15 mm)
- •* Pain still present after two weeks of a NSAID (i.e. ibuprofen 600 mg three
- •times daily, or diclophenac 50 mg 3td, or napoxen 500 mg 2 td)
- •* Pain disappears after diagnostic intra-articular injection
排除标准
- •* Edentulous (no dentition)
- •* Previous treatments acting on cartilage or bone metabolism (eg, oral or
- •intravenous bisphosphonates <1 year previously, strontium ranelate or
- •teriparatide or raloxifene <7 days prior to selection, and oral glucosamine
- •*1500 mg/day and chondroitin sulphate <3 months previously)
- •* Concurrent use of anti-inflammatory medication, steroids, muscle relaxants or
- •antidepressants
- •* Previous TMJ traumas and fractures
- •* Previous TMJ surgeries, previous intra-articular injections < 1 year before
- •* Bilateral severe TMJ derangements
- •* Bony or fibrotic ankylosis of the TMJ
- •* Known history of diabetes mellitus type 1 or 2
- •* Known history of HIV
- •* Serious systemic diseases, rheumatic disease or infectious/inflammatory
- •diseases affecting the skin of the area of the TMJ
- •* Pregnancy
- •* Coagulation disorders
- •* BMI <15
研究者
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