New York, NYNCT04098146Now EnrollingIRB Ready

Mandibular Reconstruction Clinical Trial in New York, NY

Access cutting-edge mandibular reconstruction treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by AO Innovation Translation Center

Quick Self-Assessment

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Expert Care in New York

Access mandibular reconstruction specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mandibular reconstruction treatment provided free

Apply for This New York Location

Check if you qualify for this mandibular reconstruction clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Mandibular Reconstruction Study in New York

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.

Sponsor: AO Innovation Translation Center

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT04098146) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mandibular Reconstruction Treatment Options in New York, NY

If you're searching for mandibular reconstruction treatment options in New York, NY, this clinical trial (NCT04098146) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mandibular reconstruction specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mandibular reconstruction clinical trials near you to find additional studies recruiting in your area.

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