Temporomandibular joint disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) The subjects aged 10-75 years old (inclusive) and of both sexes; 2) middle and advanced stages of TMJ osteoarthropathy, severe inflammatory or idiopathic condylar resorption, ankylosis, comminuted fracture, and joint tumor; 3) those who did not participate in other clinical verification within 3 months; 4) no acute infectious disease, psychosis, or systemic disease; 5) Voluntary subjects and signed informed consent.
Exclusion criteria
Exclusion criteria: 1) patients allergic to titanium implants; 2) patients with acute or severe infection or acute exacerbation of chronic infection; 3) patients with extensive soft tissue defects caused by surgery and insufficient soft tissue coverage of the wound after surgery; 4) patients with radiation osteomyelitis, acute and chronic osteomyelitis, osteoporosis; 5) patients with uncontrolled primary diseases of important organs such as heart, lung, brain and kidney; 6) patients with mental illness; 7) pregnant and lactating women; 8) patients unable to cooperate with treatment; 9) patients with advanced malignant tumors, distant metastasis or tumor recurrence; 10) critically ill patients, and it is difficult to make a definite evaluation of the efficacy and safety of the prosthesis; 11) use of antibiotics or chronic anti-inflammatory therapy (>=3 times per week) within 4 weeks before surgery; 12) alcohol or chronic drug abuse; 13) patients with severe immunodeficiency; 14) Uncontrolled masticatory muscle hyperfunction (night bruxism, clenching) leading to overload and loosening of titanium nails; 15) patients with poor adherence considered by the investigator to be unable to participate in the trial; 16) within the first 30 days of starting surgery (study day 0), patients were enrolled in clinical trials of other drugs or devices.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pain;Maximum mouth opening;Function;Maxillofacial morphology;Occlusion;Lateral movement; | — |
Primary
| Measure | Time frame |
|---|---|
| Quality Of Life score; | — |
Countries
China
Contacts
Ninth People's Hospital Affiliated to Shanghai JiaoTong University School of Medicine