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Construction of standardized diagnosis and treatment system and key technological innovation of temporomandibular joint-skull base-ear joint lesions

Construction of standardized diagnosis and treatment system and key technological innovation of temporomandibular joint-skull base-ear joint lesions

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035626
Enrollment
Unknown
Registered
2020-08-15
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Temporomandibular joint disease

Interventions

Group 1:Autogenous graft
Group 2:alloplastic replacement group

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. With lesions of combined skull base-joint-ear defect; 3. Did not participate in other clinical verification within 3 months; 4. Without acute infectious disease, mental illness, systemic disease; 5. Voluntary participate the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to titanium alloy plants, patients with acute or severe; 2. Infection or chronic infection, patients with large soft tissue defects caused by surgery; 3. Radiation osteomyelitis, acute and chronic osteomyelitis, osteoporosis; 4. Complicated with heart, lung, brain, kidney and other important organs without control; 5. Patients with mental illness; 6. Pregnant and lactating women; 7. Patients with advanced malignant tumor, distant metastasis or tumor recurrence are in critical condition, and difficult to make an accurate evaluation of the efficacy and safety of the prosthesis; 8. Patients were treated with antibiotics or chronic anti-inflammatory therapy within 4 weeks before operation; 9. Alcoholism or long-term drug abuse >= 3 times a week); 10. Uncontrollable masticatory muscle hyperfunction (night molars, clenching teeth) in patients with severe immune insufficiency leads to titanium nail overload and loosening; 11. Researchers believe that patients with poor compliance can not participate in the trial; 12. In the first 30 days before the start of surgery (day 0 of the study), patients participated in clinical trials of other drugs or devices.

Design outcomes

Primary

MeasureTime frame
QOL score;

Secondary

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

Countries

China

Contacts

Public ContactYang Chi

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

yangchi63@hotmail.com+86 13818712506

Outcome results

None listed

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