Temporomandibular joint disease
Conditions
Interventions
Group 1:Auotogenous bone graft
Group 2:Alloplastic joint replacement
Sponsors
Ninth People's Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. aged >=18 years old; 2. with lesions of combined skull base-joint-ear defect; 3. did not participate in other clinical verification within 3 months; 4. without acute infectious disease, mental illness, systemic disease; 5. voluntary participate the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. allergy to titanium alloy plants, patients with acute or severe; 2. infection or chronic infection, patients with large soft tissue defects caused by surgery; 3. radiation osteomyelitis, acute and chronic osteomyelitis, osteoporosis; 4. complicated with heart, lung, brain, kidney and other important organs without control; 5. patients with mental illness; 6. pregnant and lactating women; 7. patients with advanced malignant tumor, distant metastasis or tumor recurrence are in critical condition, and difficult to make an accurate evaluation of the efficacy and safety of the prosthesis; 8. patients were treated with antibiotics or chronic anti-inflammatory therapy within 4 weeks before operation; 9. alcoholism or long-term drug abuse >=3 times a week); 10. uncontrollable masticatory muscle hyperfunction (night molars, clenching teeth) in patients with severe immune insufficiency leads to titanium nail overload and loosening; 11. researchers believe that patients with poor compliance can not participate in the trial; 12. in the first 30 days before the start of surgery (day 0 of the study), patients participated in clinical trials of other drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL score;Pain;Maximum mouth opening;Function;Maxillofacial morphology ;Occlusion;Lateral movement; | — |
Countries
China
Contacts
Public ContactChi Yang
Ninth People's Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Outcome results
None listed