The PENTO Protocol in Medication-related Osteonecrosis of the Jaw
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges
About this trial
Medication-related osteonecrosis of the jaw (MRONJ) occurs after taking bisphosphonates or targeted therapies. It leads to a significant decrease in quality of life with pain, eating and chewing disorders, and malnutrition. Current treatments are only partially effective. PENTO (pentoxifylline and tocopherol) has been shown to be effective in maxillary osteoradionecrosis. The objective of this study is to evaluate the proportion of bone recovery in patients receiving PENTO in MRONJ at 12 months.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pentoxifylline+Tocopherol
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov