Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Effusion, Temporomandibular Joint Osteoarthritis, Temporomandibular Joint Pain
Conditions
Brief summary
It will be evaluate the safety of mesenchymal stem cells and adipose tissue derived stromal vascular fraction (SVF) in temporomandibular joint disease cases.
Detailed description
umbilical cord derived mesenchymal stem cells produced under GMP facility in Erciyes University and SVF produced in operation theatre.
Interventions
BIOLOGICALStem Cells
ATMP
Sponsors
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Cancer patients * Immunosupressed patients * Previous TMJ traumas and fractures * Previous TMJ surgeries * TMJ ankylosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline pain at 6 month | 6. month | using by Visual Analogue Scale (VAS) higher scores mean worse outcome |
| Change from Baseline Pain at 15th day | 15th day | using by Visual Analogue Scale (VAS); higher scores mean worse outcome |
| Change from baseline maximum mouth opening at 15th day | 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 | 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 maximum mouth opening at 3 months | 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 6 months | 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 | 1. month | using by Visual Analogue Scale (VAS) |
| Change from baseline pain at 3 month | 3. month | using by Visual Analogue Scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline 'comfort ' at 6th month | 6 months | using by Visual Analogue Scale (VAS); higher scores mean better outcome |
Countries
Turkey (Türkiye)
Contacts
Primary ContactZeynep B Gonen, DDS,PHD
Backup ContactGenkok center
Outcome results
None listed