About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Nonsegmental mandibular defect (eg. box resection/partial resection)
Trial population
Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.
Trial design
Case-control
Prospective
Treatments tested in this trial
Surgical Resection and Reconstruction
Procedure/SurgeryOne 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.
Treatment groups
Trial outcomes
Primary outcomes
Demographics
Demographics (year of birth, height in cm and weight in kilogram, race)
Comorbidities
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
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)
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.
Sponsors and contacts
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