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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
RecruitingObservational study
A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 * Patients presented with ameloblastoma affecting the mandible * Patients presented with osteosarcomas of the mandible * Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney * Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm * Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach * Informed consent obtained, ie: * Ability to understand the content of the patient information/ICF * Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB/EC approved ICF OR * Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide to provide independent written informed consent Exclusion Criteria: * 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 Intraoperative exclusion criteria: * Nonsegmental mandibular defect (eg. box resection/partial resection) * Segmental mandibular defect of less than 2 cm * Mandibular defects extending beyond the sigmoid notch into the condyles Additional exclusion criterion: • No osseous reconstruction with autologous bone performed within 18 months from resection
About the study
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.
What is being tested
- Surgical Resection and Reconstruction (procedure)
Sponsor: AO Innovation Translation Center · Participants: 300 · Started: Sep 12, 2022
Contact the study team
- Maria Medina Giner · Phone: 0795456120
Official record on ClinicalTrials.gov — NCT04098146
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.