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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 29, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting Primary completion date: Jan 1, 2026 to May 2026v11 Show 1 more changeShow less
    • Primary completion date: Jan 1, 2026 to May 2026
  2. Primary completion date: Jan 1, 2025 to Jan 1, 2026 Completion date: Jun 30, 2025 to Jun 30, 2026v10 Show 1 more changeShow less
    • Completion date: Jun 30, 2025 to Jun 30, 2026
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion date: Jan 2022 to Jan 1, 2025 Completion date: Jan 2023 to Jun 30, 2025v8 Show 1 more changeShow less
    • Completion date: Jan 2023 to Jun 30, 2025
  5. Eligibility criteria expanded, about 76 words Collaborators: 4 to 3 · Study description shortened, about 3 wordsv7 Show 2 more changesShow less
    • Collaborators: 4 to 3
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Jan 2020 to Jan 2022 Trial status: Recruiting to Enrolling by Invitation · Completion date: Jan 2020 to Jan 2023 · Site details revised at 4 of 4 sitesv6 Show 3 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Completion date: Jan 2020 to Jan 2023
    • Site details revised at 4 of 4 sites
  2. Site details revised at 3 of 4 sitesv5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Jan 2019 to Jan 2020 · Start date: Feb 15, 2017 to Apr 1, 2018 · Study sites: 5 to 4v3 Show 3 more changesShow less
    • Primary and study completion dates: Jan 2019 to Jan 2020
    • Start date: Feb 15, 2017 to Apr 1, 2018
    • Study sites: 5 to 4
  5. Start date: Jan 2017 to Feb 15, 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT03040778
Lead Sponsor University of Washington
Collaborators: University of Alabama at Birmingham, New York Center for Orthognathic and Maxillofacial Surgery, University of Michigan
Conditions Medication-related Osteonecrosis of the Jaw, Bisphosphonate-related Osteonecrosis of the Jaw, Avascular Necrosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov