NCT04098146 · AO Innovation Translation Center
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
What this study is about
forward-looking 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.
View original scientific description
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.
Interventions
PROCEDURE
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 measures
Demographics
Time frame: Baseline until resection surgery approximately 4 weeks
Demographics (year of birth, height in cm and weight in kilogram, race)
Comorbidities
Time frame: Baseline until resection surgery approximately 4 weeks
Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates
Nicotine consumption
Time frame: Baseline until resection surgery approximately 4 weeks
Current and previous nicotine use will be collected: * Number of years * Time (years) since stopped using (if applicable) * Amount of cigarettes/day
Patient reported outcome: Oral Health Impact Profile (OHIP)
Time frame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
Change in the OHIP over the follow-up period. The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes.
Difference of tumor locations of the oral squamous cell cancer
Time frame: Baseline until resection surgery ( approximately 4 weeks)
Oral squamous cell carcinoma locations acoording to follwoing regions: * Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth * Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth * Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions * Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue
Difference of tumor staging according to the TNM system
Time frame: Baseline until resection surgery ( approximately 4 weeks)
Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system. In the TNM system the "T" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size. The main tumor is usually called the primary tumor. The "N" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The "M" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis.
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
* Duration of surgery (skin to skin) in minutes * Length of hospital stay in days * Date of osseous reconstruction (if different from resection surgery) in days
Difference of surgical procedures of osseous reconstruction
Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months
* Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible * Type of bone donor/ bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s)
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
* Use of virtual surgical planning (VSP) for resection: Yes/No. * Only virtual planning and simulation of resection (no 3D printing):Yes/No. * 3D-printed biomodels: Yes/No
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Jacksonville, Florida
- Chicago, Illinois
- New Hyde Park, New York
- New York, New York
- Fort Worth, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 4, 2025 · Source of record for eligibility and locations