Recruiting

Observational Study

Sponsor:

AO Innovation Translation Center

Code:

NCT04098146

Conditions

Mandibular Reconstruction

Segmental Mandibular Defects

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical Resection and Reconstruction

Study Details

Brief 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

Study ID

NCT04098146

Start date

Sep 12, 2022

Status verified date

Aug, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Demographics [ Time Frame: Baseline until resection surgery approximately 4 weeks ]
  • Comorbidities [ Time Frame: Baseline until resection surgery approximately 4 weeks ]
  • Nicotine consumption [ Time Frame: Baseline until resection surgery approximately 4 weeks ]
  • Patient reported outcome: Oral Health Impact Profile (OHIP) [ Time Frame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months ]
  • Difference of tumor locations of the oral squamous cell cancer [ Time Frame: Baseline until resection surgery ( approximately 4 weeks) ]
  • Difference of tumor staging according to the TNM system [ Time Frame: Baseline until resection surgery ( approximately 4 weeks) ]
  • Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages [ Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months ]
  • Difference of surgical procedures of osseous reconstruction [ Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months ]
  • Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used [ Time Frame: Day of resection surgery until day of reconstruction surgery up to 18 months ]

Central Contacts and Locations

Central contacts

Maria Medina Giner

0795456120maria.medinaginer@aofoundation.org

Marco Minoia, PhD

marco.minoia@aofoundation.org

Locations

University of Florida College of Medicine

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Rui Fernandes, Prof

+1 904 244 3901Rui.Fernandes@jax.ufl.edu

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Nicolas Callahan, MD

ncall@uic.edu

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Mohammed Khan, MD

mohemmed.khan@mountsinai.org

John Peter Smith Health Network

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Roderick Kim, MD

+1 817-702-6979roderickykim@gmail.com

More Information

Sponsor

AO Innovation Translation Center

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Keywords

  • Mandibular osteotomy
  • Free bone flap
  • Reconstructive surgical procedure
  • Adjuvant Irradiation / Chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AO Innovation Translation Center on 2025-09-04.