Could a simple drug combo heal jaw bone damage?
NCT ID NCT05795647
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a combination of pentoxifylline and vitamin E can help heal jaw bone damage caused by certain osteoporosis or cancer drugs. The study will enroll 17 adults with stage 2 medication-related osteonecrosis of the jaw. Researchers will measure how many patients have less than 5 mm of exposed bone after 12 months of treatment.
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 tocopherol (vitamin E)
- What this could lead to
- If it works, this could offer a new treatment option for people with jaw bone damage caused by certain medications, potentially reducing pain and improving quality of life.
- What could go wrong
- This is a small, early-phase trial with only 17 participants, so results may not apply to everyone. The treatment may not work better than current options, and side effects are possible.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 17 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Apr 2028
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 years and older
- 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: * Age greater than or equal to 18 years * Current or past treatment with bisphosphonates (oral or IV) and/or targeted therapies (denosumab, bevacizumab) * Signs and symptoms for more than 8S with confirmation that the signs and symptoms are not of dental origin * AAOMS Stage 2 MRONJ * For patients of childbearing age, effective contraception is required Exclusion Criteria: * History of head or neck radiotherapy or maxilla metastases * Patients who have received treatment in the past (PENTO or PENTOCLO protocol) * Patients who have undergone surgery for their MRONJ within the last 3 months * Pregnant or wishing to be pregnant, breastfeeding * Patient under palliative care * Patient with hypersensitivity to pentoxifylline or tocopherol or to an excipient * History of hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactams (and clindamycin or lincomycin if applicable) or excipient of amoxicillin-a. clavulanic or clindamycin * History of jaundice/hepatic injury related to amoxicillin/clavulanic acid * Patient taking oral anticoagulants, or with a history of major bleeding or bleeding disorders * Patient taking platelet aggregation inhibitor, theophylline or aminophylline * Patient taking methotrexate, probenecid, mycophenolate mofetil, myorelaxant drugs, macrolide or streptogramin antibiotics * Patients with hepatic failure or renal failure (Cl \< 30 mL/min), * Patient with hypotension (SBP \< 90 mmHg) * Refusal to participate in the study * Patient participating in other interventional research that may interfere with the conduct of this research * Patient unable to understand the protocol * Patient under curatorship or guardianship
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Limoges university hospital
RECRUITINGLimoges, 87042, France
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