TMD
Conditions
Interventions
Experimental group:3D printing customized domestic total temporomandibular joint prosthesis replacement
Control group:Biomet stock prosthesis
Sponsors
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. moderate and advanced TMJ osteoarthrosis, severe inflammatory or idiopathic condylar resorption, ankylosis, comminuted fracture, tumors causing loss of mandibular vertical height or occlusal relationship, etc.; 3. those who have not participated in other clinical trials within 3 months; 4. No acute infectious disease, mental illness or systemic disease; 5. volunteer and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) patients who are allergic to plants in titanium alloy, polyethylene, cobalt-chromium-molybdenum alloy; 2) patients with acute or severe infection or chronic infection in acute attack; 3) patients with large-scale soft tissue defect caused by operation, and the wound was not covered by enough soft tissue after operation; 4) patients with radiation osteomyelitis, acute and chronic osteomyelitis and osteoporosis; 5) patients with uncontrolled primary diseases of heart, lung, brain, kidney and other important organs; 6) patients with mental illness; 7) pregnant and lactating women; 8) patients who are unable to cooperate with treatment; 9) patients with advanced malignant tumor, distant metastasis and tumor recurrence; 10) patients who are in such a critical condition that it is difficult to make an accurate evaluation of the effectiveness and safety of the prosthesis; 11) use antibiotics or chronic anti-inflammatory therapy within 4 weeks before surgery (>=3 times a week); 12) Alcohol or chronic drug abuse; 13) patients with severe immune insufficiency; 14) uncontrollable hyperfunction of masticatory muscles (night molars, clenching teeth) leads to overload and loosening of titanium nails; 15) the researchers believe that patients with poor compliance can not participate in the trial; 16) within 30 days before the start of the operation (day 0 of the study), the patient participated in other drugs or clinical trials of instruments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| QOL;Lateral protruding movement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain;MIO;Function;Maxillofacial morphology;Occlusion; | — |
Countries
China
Contacts
Public ContactShanyong Zhang
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed