Active — Not RecruitingPhase 3

Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)

United States100 participantsStarted 2018-04-01

Plain-language summary

The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated with standard of care alone, have decreased areas of exposed bone after one year of treatment?

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Stage 1, 2, or 3 MRONJ as defined by the AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw-2014 Update (Ruggiero 2014).
✓. History of exposure to antiresorptive medications such as bisphosphonates or RANK-L inhibitors
✓. Absence of tumor in the jaw at the time of recruitment
✓. Patients with the capacity to give informed consent

Exclusion criteria

✕. Patients with history of external radiation therapy to the jaws
✕. Patients who underwent any surgical intervention for MRONJ in the past 4 months
✕. Patients with past microvascular reconstruction of the head and neck
✕. Patients with an expected survival less than 1 year
✕. Patients with allergy or hypersensitivity to pentoxifylline, xanthines, or tocopherol
✕. Patients with planned invasive dental procedure in the next year
✕. Patients taking oral anticoagulants
✕. Patients with known hemorrhagic and coagulation disorder

What they're measuring

Change in Bone exposure area (mm^2)

Timeframe: 0 months, 1 month, 3 months, 6 months, 9 months, 12 months

Trial details

NCT IDNCT03040778

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Medication-related Osteonecrosis of the Jaw trials