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Development and preliminary clinical application of individualized total temporomandibular joint prosthesis

Development and preliminary clinical application of individualized total temporomandibular joint prosthesis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100494
Enrollment
Unknown
Registered
2025-04-10
Start date
2020-02-01
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Temporomandibular joint disease

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
10 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) The subjects aged 10-75 years old (inclusive) and of both sexes; 2) middle and advanced stages of TMJ osteoarthropathy, severe inflammatory or idiopathic condylar resorption, ankylosis, comminuted fracture, and joint tumor; 3) those who did not participate in other clinical verification within 3 months; 4) no acute infectious disease, psychosis, or systemic disease; 5) Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1) patients allergic to titanium implants; 2) patients with acute or severe infection or acute exacerbation of chronic infection; 3) patients with extensive soft tissue defects caused by surgery and insufficient soft tissue coverage of the wound after surgery; 4) patients with radiation osteomyelitis, acute and chronic osteomyelitis, osteoporosis; 5) patients with uncontrolled primary diseases of important organs such as heart, lung, brain and kidney; 6) patients with mental illness; 7) pregnant and lactating women; 8) patients unable to cooperate with treatment; 9) patients with advanced malignant tumors, distant metastasis or tumor recurrence; 10) critically ill patients, and it is difficult to make a definite evaluation of the efficacy and safety of the prosthesis; 11) use of antibiotics or chronic anti-inflammatory therapy (>=3 times per week) within 4 weeks before surgery; 12) alcohol or chronic drug abuse; 13) patients with severe immunodeficiency; 14) Uncontrolled masticatory muscle hyperfunction (night bruxism, clenching) leading to overload and loosening of titanium nails; 15) patients with poor adherence considered by the investigator to be unable to participate in the trial; 16) within the first 30 days of starting surgery (study day 0), patients were enrolled in clinical trials of other drugs or devices.

Design outcomes

Secondary

MeasureTime frame
Pain;Maximum mouth opening;Function;Maxillofacial morphology;Occlusion;Lateral movement;

Primary

MeasureTime frame
Quality Of Life score;

Countries

China

Contacts

Public ContactYang Chi

Ninth People's Hospital Affiliated to Shanghai JiaoTong University School of Medicine

yangchi63@hotmail.com+86 138 1871 2506

Outcome results

None listed

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