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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

Key facts

Who runs it
AO Innovation Translation Center
Where
Chicago, Fort Worth, Jacksonville, New Hyde Park, and New York, United StatesSee the 5 sitesAlso in 7 other countries, 14 sites
Trial code
Status
Recruiting
People taking part
300 people, planned
Started
12 Sept 2022
Expected to end
31 Dec 2030
Type of study
Observational
Treatments tested
  • Surgical Resection and Reconstruction
Record updated
4 September 2025

Who can take part

Age
18 years and older
Sex
Women and men

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • No osseous reconstruction with autologous bone performed within 18 months from resection
  • Tumors affecting the condyle
  • Patients under palliative care
  • Segmental mandibular defect of less than 2 cm
  • Mandibular defects extending beyond the sigmoid notch into the condyles; Additional exclusion criterion:

Where in United States

Also in 7 other countries, 14 sites

  • University of Illinois ChicagoChicago, United StatesTaking people
  • John Peter Smith Health NetworkFort Worth, United StatesContact: Roderick Kim, MDTaking people
  • University of Florida - College of MedicineJacksonville, United StatesContact: Rui Fernandes, ProfTaking people
  • Northwell Health-Cancer InstituteNew Hyde Park, United StatesContact: Brett MilesNot yet recruiting
  • Mount Sinai HospitalNew York, United StatesContact: Mohammed Khan, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Mandibular Reconstruction

    Patients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care

    Treatment: Surgical Resection and Reconstruction

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
Record updated
4 September 2025