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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pentoxifylline+Tocopherol
DrugTreatment will consist of pentoxifylline LP 400 mg morning and evening, combined with tocopherol 500 mg morning and evening
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: PentoxifyllineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Exposure bone area (EBA)
exposure bone area (EBA) less than 5 mm at 12 months. It will be expressed as the percentage of patients who achieved healing (EBA \< 5 mm) at 12 months.
Time frame
Month 12Secondary outcomes
1
SOMA score
describe the evolution of the modified SOMA score (pain, chewing, bone exposure size, trismus, radiological appearance)
Time frame
Month 1, Month 3, Month 6, Month 122
Nutritional parameters evolution (albuminemia)
describe the nutritional parameters evolution albuminemia
Time frame
Month 1, Month 3, Month 6, Month 123
Nutritional parameters evolution (pre-albuminemia)
describe the nutritional parameters evolution pre-albuminemia
Time frame
Month 1, Month 3, Month 6, Month 124
Nutritional parameters evolution (weight)
describe the nutritional parameters evolution weight
Time frame
Month 1, Month 3, Month 6, Month 12Sponsors and contacts
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Source ClinicalTrials.gov