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Pentoxifylline + Tocopherol for Osteonecrosis of the Jaw
Phase 3
Waitlist Available
Led By Jasjit Dillon, DDS, MBBS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with Stage 1, 2, or 3 MRONJ as defined by the AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw-2014 Update (Ruggiero 2014)
Absence of tumor in the jaw at the time of recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Awards & highlights
Study Summary
This trial is testing whether a combination of pentoxifylline and tocopherol decreases the amount of exposed bone in MRONJ patients compared to standard of care alone.
Who is the study for?
This trial is for individuals with Medication-related Osteonecrosis of the Jaw (MRONJ) who have been treated with antiresorptive medications. They must not have tumors in the jaw, severe heart or kidney issues, bleeding disorders, or be pregnant. Participants should not be on certain drugs like CYP1A2 inhibitors and must agree to avoid vitamin E supplements during the study.Check my eligibility
What is being tested?
The trial tests if adding Pentoxifylline and Tocopherol (PENTO) to standard care is more effective than standard care alone in reducing exposed bone areas in MRONJ patients after one year. Patients are randomly assigned to receive either PENTO plus standard care or a placebo with standard care.See study design
What are the potential side effects?
Potential side effects from Pentoxifylline may include dizziness, headache, nausea, and digestive upset. Tocopherol can cause fatigue, blurred vision, and gastrointestinal discomfort. The severity of side effects varies among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stage 1, 2, or 3 jawbone damage related to medication use.
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I do not have a tumor in my jaw.
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I understand the details of the clinical trial and can agree to participate.
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I have taken medications like bisphosphonates or RANK-L inhibitors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bone exposure area (mm^2)
Secondary outcome measures
Change in MRONJ Stage
Change in Pain
Change in osseous anterior-posterior linear dimension on orthopantomogram
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard of Care + PENTOExperimental Treatment2 Interventions
The current standard of care for MRONJ as outlined by the American Association of Oral and Maxillofacial Surgeons position paper based on stage of disease (Ruggiero 2014) AND PENTO regimen consisting of 400mg pentoxifylline (PTX) and 400IU tocopherol twice-daily PO for a total of 800mg/day PTX and 800 IU/day tocopherol
Group II: Standard of CarePlacebo Group1 Intervention
The current standard of care for MRONJ as outlined by the American Association of Oral and Maxillofacial Surgeons position paper based on stage of disease (Ruggiero 2014). Placebo drugs to be taken in the control group 2 pills BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocopherol
1993
Completed Phase 4
~220
Pentoxifylline
2021
Completed Phase 4
~1140
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,251 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,581 Previous Clinical Trials
2,277,929 Total Patients Enrolled
New York Center for Orthognathic and Maxillofacial SurgeryUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidneys are not working well (severe renal failure).I am currently taking medication that affects my liver enzyme CYP1A2.I have a heart condition related to poor blood flow.I am not taking vitamin E or agree to stop if I join the study.I have stage 1, 2, or 3 jawbone damage related to medication use.I do not have a tumor in my jaw.I am currently taking blood thinners.I understand the details of the clinical trial and can agree to participate.I have a vitamin K deficiency.I had surgery for jawbone problems due to cancer treatment within the last 4 months.I am allergic to pentoxifylline, xanthines, or tocopherol.I have been diagnosed with MRONJ without any visible bone.I have been diagnosed with low blood pressure.I am currently pregnant or breastfeeding.I had surgery to repair small blood vessels in my head or neck.I have severe liver disease.I have taken medications like bisphosphonates or RANK-L inhibitors.I am currently taking blood thinner pills.I have had serious bleeding problems or major bleeding in my eyes.My dental condition changed after getting an alginate impression.I have discussed my use of aspirin or other blood-thinning medications with my doctor to ensure safe participation in the study.I have had radiation therapy to my jaws.I have a serious heart rhythm problem.I have a bleeding or clotting disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care + PENTO
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there many places in this state where people can participate in this trial?
"There are 4 sites currently enrolling patients for this study, with additional locations in Lake Success, Seattle and Ann Arbor. If you decide to participate in this trial, please choose the location nearest to you so that travelling is kept at a minimum."
Answered by AI
Does this test include any seniors in its sample size?
"This particular trial is open to patients between 18-90 years old, which falls in line with the general age range for clinical trials. There are however eighteen separate clinical trials that are available for minors and eighty-five different ones catered to seniors."
Answered by AI
What does the research indicate PENTO is an effective treatment for?
"PENTO is often used as part of the Standard of Care to treat vitamin deficiency. This course of treatment is also effective against other conditions such as parenteral nutrition, long-chain omega-3 fatty acid supplementation, and alcoholic liver diseases."
Answered by AI
Are there many examples in the medical literature of Standard of Care + PENTO?
"PENTO was first trialled in 2008 as a neonatal care standard at Shaare Zedek Medical Center. To date, there have been 18359 completed studies worldwide. As of now, there are 24 ongoing clinical trials; many of which are based out of Lake Success, New york."
Answered by AI
What does the FDA say about using PENTO in combination with Standard of Care?
"The safety of Standard of Care + PENTO was given a 3 by our team at Power. This is due to the fact that this is Phase 3 trial, which means there is some evidence supporting efficacy as well as multiple rounds data indicating safety."
Answered by AI
To qualify for this clinical trial, what are the requirements that potential participants must meet?
"Individuals with avascular necrosis who are aged between 18 and 90 may be eligible for this trial. Currently, the research team is trying to recruit 100 patients in total."
Answered by AI
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