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Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis

NCT04098146 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-09-04

No results posted yet for this study

Summary

Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.

Conditions

  • Mandibular Reconstruction
  • Segmental Mandibular Defects

Interventions

PROCEDURE

Surgical Resection and Reconstruction

One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.

Sponsors & Collaborators

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Rüdiger Zimmerer, PD, MD · University of Leipzig

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2030-06-30
Completion
2030-12-31

Countries

  • United States
  • Germany
  • Japan
  • Netherlands
  • Portugal
  • Spain
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098146 on ClinicalTrials.gov