RecruitingNot Applicable

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

United States, Germany, Japan300 participantsStarted 2022-09-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 affe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demographics

Timeframe: Baseline until resection surgery approximately 4 weeks

Comorbidities

Timeframe: Baseline until resection surgery approximately 4 weeks

Nicotine consumption

Timeframe: Baseline until resection surgery approximately 4 weeks

Patient reported outcome: Oral Health Impact Profile (OHIP)

Timeframe: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months

Difference of tumor locations of the oral squamous cell cancer

Timeframe: Baseline until resection surgery ( approximately 4 weeks)

Difference of tumor staging according to the TNM system

Timeframe: 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

Timeframe: Day of resection surgery until day of reconstruction surgery up to 18 months

Trial details

NCT IDNCT04098146

SponsorAO Innovation Translation Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-06-30

Contact for this trial

Maria Medina Giner

0795456120 maria.medinaginer@aofoundation.org

View on ClinicalTrials.gov More Mandibular Reconstruction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Demographics

Timeframe: Baseline until resection surgery approximately 4 weeks

Comorbidities

Timeframe: Baseline until resection surgery approximately 4 weeks

Nicotine consumption

Timeframe: Baseline until resection surgery approximately 4 weeks

Patient reported outcome: Oral Health Impact Profile (OHIP)

Timeframe: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months

Difference of tumor locations of the oral squamous cell cancer

Timeframe: Baseline until resection surgery ( approximately 4 weeks)

Difference of tumor staging according to the TNM system

Timeframe: 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

Timeframe: Day of resection surgery until day of reconstruction surgery up to 18 months