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A clinical study of the domestic standard temporomandibular joint prosthesis replacement

A clinical study of the domestic standard temporomandibular joint prosthesis replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-16009865
Enrollment
Unknown
Registered
2016-11-15
Start date
2016-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular joint disease

Interventions

Experimental group:Domestic standard temporomandibular joint prosthesis
Control group:Biomet standard temporomandibular joint prosthesis

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years male and female; 2. Patients of temporomandibular joint osteoarthrosis, tumor, ankylosis, absorption; 3. patients are willing to carry out the evaluation of the requirements of the validation program; 4. Before the treatment, the patient agrees to sign the informed consent approved by EC.

Exclusion criteria

Exclusion criteria: 1. Growth stage patients; 2. Allergic patients with metal or polymer materials; 3. Patients with overt bleeding tendency and hematologic disorders; 4. Patients with malignant tumor and end stage disease; 5. Pregnant women; 6. Patients of refusal to sign the informed consent; 7. Patients at acute stage of any disease; 8. Patients unable to follow up.

Design outcomes

Primary

MeasureTime frame
Pain;Duration of operation;—

Countries

China

Contacts

Public ContactHe Dongmei

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine

lucyhe119@163.com+86 15900837931

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026