Pentoxifylline + Tocopherol for Osteonecrosis of the Jaw
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking additional vitamin E if you decide to enroll. If you are taking oral anticoagulants, you cannot participate. You should also discuss with the study team if you are taking aspirin or other medications that affect blood clotting to see if the study is a good fit for you.
What data supports the effectiveness of the drug pentoxifylline and tocopherol for osteonecrosis of the jaw?
Is the combination of pentoxifylline and tocopherol safe for humans?
How does the drug Pentoxifylline + Tocopherol differ from other treatments for osteonecrosis of the jaw?
Pentoxifylline and tocopherol are unique because they combine antioxidant and antifibrotic properties, which help in healing the jaw bone and mucosa, especially in cases related to medication use. This combination has shown promising results in both preventing and treating osteonecrosis of the jaw, particularly after dental extractions, compared to traditional surgical approaches alone.12345
What is the purpose of this trial?
The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated with standard of care alone, have decreased areas of exposed bone after one year of treatment?
Research Team
Jasjit Dillon, DDS, MBBS
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for individuals with Medication-related Osteonecrosis of the Jaw (MRONJ) who have been treated with antiresorptive medications. They must not have tumors in the jaw, severe heart or kidney issues, bleeding disorders, or be pregnant. Participants should not be on certain drugs like CYP1A2 inhibitors and must agree to avoid vitamin E supplements during the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the PENTO regimen or standard of care for 12 months
Interim Analysis
Interim analyses are performed at 3 and 6 months to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Pentoxifylline
- Placebo
- Tocopherol
Pentoxifylline is already approved in United States, Canada, European Union for the following indications:
- Intermittent claudication
- Intermittent claudication
- Intermittent claudication
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
University of Alabama at Birmingham
Collaborator
New York Center for Orthognathic and Maxillofacial Surgery
Collaborator
University of Michigan
Collaborator