Actively Recruiting

Age: 18Years +
All Genders
NCT04098146

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

Led by AO Innovation Translation Center · Updated on 2025-09-04

300

Participants Needed

19

Research Sites

433 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pathological diagnosis of mandibular involvement by oral tumors, drug-induced osteonecrosis, or metastatic mandibular lesions
  • Age 18 years and older
  • Bisphosphonate related osteonecrosis of the mandible
  • Immunomodulatory drugs induced mandibular osteonecrosis
  • Patients with ameloblastoma affecting the mandible
  • Patients with osteosarcomas of the mandible
  • Patients with oral metastases related mandibular lesions indicated for segmental resection
  • Undergoing primary curative treatment with segmental mandibular resection 2 cm or larger
  • Plan to undergo mandibular reconstruction with autologous bone using primary or secondary approach
  • Ability to understand and provide informed consent or have consent provided according to approved procedures
Not Eligible

You will not qualify if you...

  • Tumors affecting the condyle
  • Patients under palliative care
  • Previous extensive mandibular surgeries that may affect study outcomes
  • Intraoperative exclusion: nonsegmental mandibular defect or defect less than 2 cm
  • Mandibular defects extending beyond the sigmoid notch into the condyles
  • No autologous bone reconstruction performed within 18 months after resection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

University of Florida College of Medicine

Jacksonville, Florida, United States, 32209

Actively Recruiting

2

University of Illinois Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

3

Northwell Health Cancer Institute

New Hyde Park, New York, United States, 11042

Not Yet Recruiting

4

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

5

John Peter Smith Health Network

Fort Worth, Texas, United States, 76104

Actively Recruiting

6

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

7

University Hospital RWTH Aachen

Aachen, Germany, 52074

Actively Recruiting

8

University Hospital Charité

Berlin, Germany, 13353

Actively Recruiting

9

Hannover Medical School

Hanover, Germany, 30625

Actively Recruiting

10

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

11

University Hospital Leipzig

Leipzig, Germany, 04103

Actively Recruiting

12

Klinikum der LMU München

Munich, Germany, 80337

Actively Recruiting

13

University Hospital Ulm

Ulm, Germany, 89081

Actively Recruiting

14

Shimane University

Izumo, Japan, 693-0001

Not Yet Recruiting

15

Erasmus University Medical Centre

Rotterdam, Netherlands, 3015 GD

Actively Recruiting

16

Luz Hospital

Lisbon, Portugal, 1500-650

Not Yet Recruiting

17

12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

18

Uppsala University Hospital

Uppsala, Sweden, 75185

Actively Recruiting

19

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

M

Maria Medina Giner

CONTACT

M

Marco Minoia, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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