Evaluating PENTO for treating jaw bone issues from medication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of the PENTO protocol, which combines pentoxifylline and tocopherol, in treating medication-related osteonecrosis of the jaw (MRONJ). Patients with AAOMS stage 2 MRONJ, characterized by exposed bone and significant symptoms, will receive the treatment alongside antibiotic therapy. The study will measure the proportion of bone recovery over a 12-month period, addressing the limitations of current treatments that have shown only partial effectiveness. This prospective phase IIa study seeks to provide robust evidence on the efficacy of PENTO in a larger patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Limoges university hospital
  Limoges, France Recruiting

Study contacts

• Principal investigator: Julie USSEGLIO, Dr — University Hospital, Limoges
• Study coordinator: Julie USSEGLIO, Dr
• Email: julie.usseglio@chu-limoges.fr
• Phone: +33 (0) 555 056 120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.