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A randomization, positive controlled trial for personalized total temporomandibular joint prosthesis reconstruction

A randomization, positive controlled trial for personalized total temporomandibular joint prosthesis reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009838
Enrollment
Unknown
Registered
2016-11-13
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 bone disease

Interventions

Sponsors

Shanghai 9th People's Hospital, Affiliate to Shanghaijiaotng University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40 to 75 years; 2. Benign tumors or other masses of TMJ which cause perforation of skull base,or mandibular benign lesion which affect TMJ; 3. Did not participate in any clinical trials in the last three monthes; 4. Without acute infectious diseases,mental diseases,system disease; 5. Agree and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Allegic to titanium alloy implants; 2. Acute or serious infection,or acute attack of chronic infection; 3. A large range of soft issue defects without enough soft issue cover after operation; 4. Radioactive osteomyelitis, acute or chronic osteomyelitis, Osteoporosis; 5. With heart, lung,brain, kidney and other important organs diseases uncontrolled; 6. With mental diseases; 7. Pregnant or lactating woman; 8. With non-compliant; 9. Malignant tumor in middle and advanced stage,tumor distant metastasis or recurrent; 10. Patient is in a critical condition and hard to evaluate its efficacy and safety.

Design outcomes

Primary

MeasureTime frame
Pain;Mouth Openning;

Secondary

MeasureTime frame
Style of mouth openning;Occlusal force;Occlusal relationship;Lateral and protrusive movement;Cranio facial morphology;Operation efficiency;Quality of life scale;Adverse events rate;

Countries

China

Contacts

Public ContactShanyong Zhang

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine. Department of Oral and Maxillofacial Surgery

zhangshanyong@126.com+86 13817673406

Outcome results

None listed

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