Stem Cells Transplantation for Temporomandibular Joint Disease: Phase I/II Study
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline maximum mouth opening at 3 months
研究概览
简要总结
It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.
详细描述
umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic temporomandibular arthritic disorder
- •History of pain and joint noises for at least 3 months
- •Must have more than VAS 5 TMJ pain
- •must have internal derangement of TMJ
- •Limited mouth opening
- •Magnetic resonance imaging evidence of effusion or degeneration
- •Already treated with conservative methods (occlusal splint,pharmacological and/or physio-kinesio therapy) without satisfactory benefit.
排除标准
- •Cancer patients
- •Immunosupressed patients
- •Previous TMJ traumas and fractures
- •Previous TMJ surgeries
- •TMJ ankylosis
结局指标
主要结局
Change from baseline maximum mouth opening at 3 months
时间窗: 3. month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at third month; higher scores means a better outcome
Change from baseline maximum mouth opening at 15th day
时间窗: 15th day
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly
Change from baseline maximum mouth opening at 1 month
时间窗: 1. month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at first month; higher scores means a better outcome
Change from baseline pain at 3 month
时间窗: 3. month
using by Visual Analogue Scale (VAS)
Change from baseline pain at 6 month
时间窗: 6. month
using by Visual Analogue Scale (VAS) higher scores mean worse outcome
Change from Baseline Pain at 15th day
时间窗: 15th day
using by Visual Analogue Scale (VAS); higher scores mean worse outcome
Change from baseline maximum mouth opening at 6 months
时间窗: 6. month
the distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly at 6th month,higher scores means a better outcome
Change from baseline pain at 1 month
时间窗: 1. month
using by Visual Analogue Scale (VAS)
次要结局
- Change from baseline 'comfort ' at 6th month(6 months)
研究者
Zeynep Burcin GONEN
Associate Professor
TC Erciyes University