Temporomandibular joint osteoarthritis
Conditions
Interventions
Experimental group 1 (high dose, 50 mL):1.2 mL of hPBMC-EVs (high dose, 50 mL) was injected into the supra TMJ on the affected side. The total course consisted of 3 injections with an interval of 2 we
Experimental group 2 (low dose, 20 mL):1.2mL of hPBMC-EVs (low dose, 20 mL) was injected into the supra TMJ on the affected side. The total course consisted of 3 injections with an interval of 2 weeks
Control group:1.2 mL sodium hyaluronate was injected into the superior cavity of the temporomandibular joint of the affected side. The total course of treatment included 3 injections with an interval
Sponsors
Affiliated Stomatology Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with TMJ-OA according to the DC/TMD diagnostic criteria; 2. When signing the informed consent, the age should be >= 18 years old, no gender limit; 3. BMI 18.5-35kg/m^2, and the weight of males is >= 50kg, and the weight of females is >= 45kg; 4. No TMD related treatment; 5. Patients fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent, and are willing to complete the entire trial process according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1. Those who have doubts about the treatment plan or those who have obvious mental and psychological disorders; 2. Severe heart, lung, liver and kidney dysfunction; 3. HIV antibody, HBsAg, HCV antibody or syphilis serological test results are positive; 4. Those who have a history of infection within 1 month before screening, require hospitalization and/or antibiotic treatment, or are currently using systemic hormones (glucocorticoids), immunosuppressants or cytotoxic therapy; 5. Those who have been diagnosed with hyperthyroidism or hypothyroidism within one year before screening and are still taking medication, or have a history of thyroid disease and thyroid-stimulating hormone (TSH) is higher than 1.2 times the upper limit of normal or lower than 0.8 times the lower limit of normal; 6. Those with a history of epilepsy (excluding the history of febrile convulsions in children); 7. Severe alcohol or drug dependence (excluding caffeine or nicotine) within 1 year before screening, or daily alcohol intake of 5 units or more (1 unit = 360 mL of beer or 45 mL of liquor or 120 mL of wine); 8. Those with severe or unstable cardiovascular, respiratory, liver, kidney, blood, endocrine and central nervous system diseases; 9. Pregnant and lactating patients; 10. Patients with rheumatism and rheumatoid arthritis; 11. Patients with temporomandibular joint tumors; 12. Patients with contraindications or allergies to the treatment in this study; 13. Patients who are considered by the investigator to be inappropriate to participate in this trial; 14. Other patients who are not suitable for injection therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cone beam computer tomography imaging;Blood routine;Liver and kidney function tests;Efficiency of pain improvement;Maximum opening and mandibular movement;Clicking of mandibular joints;Detection of inflammatory factor expression in joint lavage fluid; | — |
Countries
China
Contacts
Public ContactZhang Qingbin
Affiliated Stomatology Hospital of Guangzhou Medical University
Outcome results
None listed