Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)

Launched by UNIVERSITY OF WASHINGTON · Feb 1, 2017

Keywords

ClinConnect Summary

HYPOTHESES

HA: Among patients with MRONJ, after 12 months of treatment with PENTO, the area of exposed bone in the PENTO group will be different than the area of exposed bone in the standard therapy group.

H0: Among patients with MRONJ, after 12 months of treatment with PENTO, the area of exposed bone in the PENTO group will equal the area of exposed bone in the standard therapy group.

SPECIFIC AIMS

To determine if the PENTO regimen in addition to the standard of care treatment for MRONJ significantly reduces the area of exposed bone compared to standard of care alone. Standard of care ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Stage 1, 2, or 3 MRONJ as defined by the AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw-2014 Update (Ruggiero 2014).
• • 2. History of exposure to antiresorptive medications such as bisphosphonates or RANK-L inhibitors
• • 3. Absence of tumor in the jaw at the time of recruitment
• • 4. Patients with the capacity to give informed consent
• Exclusion Criteria:
• • 1. Patients with history of external radiation therapy to the jaws
• • 2. Patients who underwent any surgical intervention for MRONJ in the past 4 months
• • 3. Patients with past microvascular reconstruction of the head and neck
• • 4. Patients with an expected survival less than 1 year
• • 5. Patients with allergy or hypersensitivity to pentoxifylline, xanthines, or tocopherol
• • 6. Patients with planned invasive dental procedure in the next year
• • 7. Patients taking oral anticoagulants
• • 8. Patients with known hemorrhagic and coagulation disorder
• • 9. Patients with a vitamin K deficiency due to any cause
• • 10. Female patients who are pregnant or lactating
• • 11. Patients with history of serious bleeding or extensive retinal hemorrhage
• • 12. Patients with ischemic heart diseases, including, but not limiting, recent myocardial infarction
• • 13. Patients with serious cardiac arrhythmia
• • 14. Patients with severe liver disease
• • 15. Patients with severe renal failure (Creatinine clearance \<30 mL/min)
• • 16. Patients with diagnosed hypotension
• • 17. Patients taking CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine)
• • 18. Diagnosis of MRONJ with no exposed bone
• • 19. Patient cannot tolerate impressions of exposed bone in a clinical setting, if needed.
• • 20. There is a change in the patient's clinical presentation (tooth extraction, sequestrectomy) from alginate impression, if impression is indicated.
• • 21. Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study
• • 22. • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
• • 23. Patients who are taking additional vitamin E, or you will confirm they will stop taking vitamin E if they decide to enroll in this study.
• • 24. Patients who are taking oral anticoagulant medications.
• • 25. Discuss with patients taking aspirin and other supplements/medications that impact coagulation to determine if the study is a good fit, and will exclude an individual whose situation or condition may interfere with safe participation in the study.