Temporomandibular joint and mandible disease
Conditions
Interventions
trial group:TMJ-mandibular joint prosthesis implantation
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subjects are over 20 years old (inclusive), gender is not limited; 2) Lesions that cause TMJ-mandibular joint defect; 3) Those who have not participated in other clinical verification within 3 months; 4) Take the test voluntarily and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients who are allergic to titanium alloy internal plants; 2) Patients with acute or severe infection or chronic infection in the acute stage; 3) Patients whose surgery has caused extensive soft tissue defects and the wounds do not have enough soft tissue coverage after surgery; 4) Patients with acute 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 cannot cooperate with treatment; 9) Patients with advanced malignant tumors, distant metastases, and tumor recurrence; 10) Patients whose condition is critically ill, and it is difficult to make an accurate assessment of the effectiveness and safety of the prosthesis; 11) Use antibiotics or chronic anti-inflammatory therapy (>=3 times per week) within 4 weeks before surgery; 12) Alcoholism or long-term drug abuse; 13) Patients with severe immune insufficiency; 14) Uncontrollable hyperfunction of the masticatory muscles (night bruxism, clenching teeth) leading to overload and loosening of titanium nails; 15) Patients who the researcher believes that they have poor compliance and cannot participate in the trial; 16) In the first 30 days before the start of surgery (study day 0), the patient participated in clinical trials of other drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| pain;mouth opening;masticatory function;craniofacial morphology;occluding relation;Lateral and forward moving; | — |
Countries
China
Contacts
Public ContactMinjie Chen
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed