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Evaluate the application of customized PEEK with Fibula Free Flap in Mandible Reconstruction

Evaluate the application of customized PEEK with Fibula Free Flap in Mandible Reconstruction

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034259
Enrollment
Unknown
Registered
2020-06-30
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Mandible reconstruction

Interventions

Sponsors

Department of Oral and Maxillofacial Head and Neck Oncology, the Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years old; 2. Gender: male or female; 3. Patients with benign mandible lesions need surgery (mandibular segmental resection) and fibula flap repair at the same time; 4. Patients without history of head and neck radiotherapy; 5. The range of surgical resection: segmental resection of the mandible without limiting the length of the defect; 6. The occlusal relationship of dentition is stable and masticatory disorder is eliminated; 7. Patients with sufficient cognitive ability can complete the scale independently; 8. Patients who voluntarily sign informed consent will participate in this clinical trial.

Exclusion criteria

Exclusion criteria: 1. Patients with vascular variation of fibular artery and vein; 2. The patients contraindicated by general anesthesia; 3. Pregnant women / lactating patients; 4. Patients with poor coordination.

Design outcomes

Primary

MeasureTime frame
the PEEK implant failure rate within 12 months. ;

Secondary

MeasureTime frame
Facial symmetry after mandible reconstrcution.;Crown:root ratio after mandible reconstruction using fibula flap.;Occlusal force after dental rehabilitation in mandible reconstruction.;

Countries

China

Contacts

Public ContactXingzhou Qu

The Ninth People's Hospital Affiliated to Medical School of Shanghai Jiaotong University

omfs_headneck@yahoo.com+86 13601843432

Outcome results

None listed

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