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Could a common muscle drug and vitamin e heal jaw bone death?

NCT ID NCT03040778

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2018

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 90 years

Sex

Anyone

Healthy volunteers

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

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.

avascular necrosis Bisphosphonate-Associated Osteonecrosis of the Jaw osteonecrosis osteonecrosis of the jaw

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • New York Center for Orthognathic and Maxillofacial Surgery

    Lake Success, New York, 11042, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109-0018, United States

  • University of Washington

    Seattle, Washington, 98195, United States

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