Testing modified PENTOCLO (mPENTOCLO) against a placebo for osteoradionecrosis

Exclusion

• −Patients on medication with a potential but low risk of QTc prolongation (e.g., ondansetron, SSRIs) may be included if a post-initiation ECG conducted within 24-48 hours of starting ciprofloxacin or fluconazole confirms that there is no significant QTc prolongation
• −Patients diagnosed with retinitis pigmentosa
• −Inability to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
• −Major surgical procedure planned (more extensive than sequestrectomy)
• −Severe trismus and inability to obtain intraoral photographs
• −Contraindications for HBOT: pneumothorax, bullous disease, uncontrolled hypertension, uncontrolled epilepsy, claustrophobia
• −Known QT prolongation as documented on an in-date ECG (within 60 days prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →) are excluded. Patients with the QTc prolongation associated with a correctable cause (e.g., electrolyte imbalance or drug-induced), and corrected QTc prior to enrolment into the study as documented on 12 lead ECG will be eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →
• −Patients requiring concurrent use of medications known to significantly prolong the QT interval with a high risk of clinical impact (e.g., erythromycin, cisapride, astemizole, pimozide or quinidine) are excluded unless safe discontinuation or substitution of these medications is feasible prior to initiation of the study
• −History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanate
• −Moderate to severe active liver disease (class B or C Pugh-Child Score) or active liver disease with significant acute elevation of LFT values
• −History of myasthenia gravis
• −Patients with a history of nontraumatic tendon disorders with severe functional impairment (i.e., significant swelling of the affected tendon, or partial tendon tear documented on clinical examination or imaging)
• −Patients who have previously experienced peripheral neuropathy due to exposure to antibiotics
• −Persistent or recurrent cancer and active neoplastic pathology will be excluded
• −Patients with documented Vitamin K deficiency
• −Patients taking additional Vitamin E
• −Patients with concomitant prescription of anti-resorptive or anti-angiogenic medications (e.g. risedronate, alendronate, aIbandronate, zoledronic acid, pamidronate, etidronate or prescription of denosusamab, etc.)
• −Patients diagnosed with clinically significant anemia
• −Contraindications to mPENTOCLO (inability to swallow medication; pregnancy or lactating; allergy to any study drug; currently on oral anticoagulants; hemorrhagic/coagulation disorder; Vitamin K deficiency; active unresolved cardiac disease; severe liver or kidney disease (CrCl\<30 mL/min))
• −Previous treatment for ORN (PENTOCLO, HBOT or surgery)
• −Smokers, high alcohol intake (average of \>2 standard drinks per day), sepsis, severe undernourishment and severe immunodeficiency conditions (e.g. HIV, autoimmune disease, immune-compromised)