Could a common muscle drug and vitamin e heal jaw bone death?
NCT ID NCT03040778
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether a combination of pentoxifylline (a muscle pain drug) and vitamin E can help heal jaw bone damage caused by osteoporosis or cancer treatments. About 100 people with medication-related jaw bone death will receive either the drug combo plus standard care, or standard care alone. The main goal is to see if the exposed bone area shrinks after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pentoxifylline and Vitamin E (tocopherol)
- What this could lead to
- If it works, this drug combination could become a non-surgical treatment to heal jaw bone damage caused by osteoporosis or cancer medications.
- What could go wrong
- This is a mid-stage trial with only 100 participants, so results may not apply to everyone. The drugs may not shrink the bone exposure better than standard care alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2018
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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New York Center for Orthognathic and Maxillofacial Surgery
Lake Success, New York, 11042, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35242, United States
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University of Michigan
Ann Arbor, Michigan, 48109-0018, United States
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University of Washington
Seattle, Washington, 98195, United States
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