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A prospective clinical trial on autologous tissue and prosthesis repair and reconstruction of temporomandibular joint and its surrounding structure tumors

A prospective clinical trial on autologous tissue and prosthesis repair and reconstruction of temporomandibular joint and its surrounding structure tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127174
Enrollment
Unknown
Registered
2026-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Temporomandibular joint and its surrounding structures skull base tumors

Interventions

Experimental Group:Temporomandibular joint reconstruction with artificial prosthesis
Control Group:Autogenous BONE RECONSTRUCTION

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, regardless of gender; 2. The patient was diagnosed as a temporomandibular joint mass or a temporomandibular joint ear mass or a temporomandibular joint skull base mass or a temporomandibular joint skull base ear mass.

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 the postoperative wound was not covered by enough soft tissue; 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. People with mental illness; 7. Pregnant and lactating women; 8. Patients who are unable to cooperate with treatment; 9. Patients with advanced malignant tumors, distant metastasis and tumor recurrence; 10. Patients with advanced malignant tumors, distant metastasis and tumor recurrence; 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 who could not participate in the trial because of poor compliance according to the investigator; 16. Patients were enrolled in a clinical trial of another drug or device within the three months before surgery (study day 0).

Design outcomes

Primary

MeasureTime frame
Maximum mouth opening;

Secondary

MeasureTime frame
Quality Of Life score;The recurrence rate;Pain;Diet;Mandibular function;Bone integration;Maxillofacial morphology;Lateral/forward movement;

Countries

China

Contacts

Public ContactYang Chi

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

yangchi63@hotmail.com+86 21 2327 1699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026