Ankylosis of the temporomandibular joint
Conditions
Interventions
Control group:Biomet standard prosthesis replacement
Treatment group:Chinese metal-polymer integrated customized prosthesis replacement
Sponsors
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subjects are aged 18-75 years old (inclusive), regardless of gender; 2) Cases requiring joint replacement due to TMJ osseous rigidity; 3) Those who have not participated in other clinical validation within 3 months; 4) No acute infectious disease, mental illness, systemic disease; 5) Volunteer and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who are allergic to plants in titanium alloy; 2) Patients with acute or severe infection or chronic infection in the acute phase; 3) Patients with extensive soft tissue defects caused by surgery and postoperative wounds without adequate soft tissue coverage; 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) People with mental illness; 7) Pregnant and lactating women; 8) Patients who cannot cooperate with treatment; 9) Patients with middle and advanced malignant tumors, distant metastasis of tumors, and tumor recurrence; 10) Patients with critical conditions, it is difficult to make an accurate evaluation of the effectiveness and safety of the prosthesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum mouth opening degree, MIO; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mouth opening;Occlusion;Mandibular movement;Maxillofaical shape; | — |
Countries
China
Contacts
Public ContactShanyong Zhang
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed