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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center

About this trial

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.

Eligibility criteria

Qualifiers

The study includes patients with an initial pathological/histologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.

Age 18 years and older

Bisphosphonate related osteonecrosis of the mandible

Immunomodulatory drugs induced mandibular osteonecrosis

Disqualifiers

Tumors affecting the condyle

Patients under palliative care

Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures

Nonsegmental mandibular defect (eg. box resection/partial resection)

Trial design

Treatments tested in this trial

  • Surgical Resection and Reconstruction

Treatment groups

300 Participants
are divided into 1 treatment group