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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03040778
Other study ID # STUDY00004779
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date April 1, 2018
Est. completion date June 30, 2026

Study information

Verified date May 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pentoxifylline
Pentoxifylline is a commonly used medication for muscle pain associated with peripheral artery disease. It is a methylated xanthine derivative that improves peripheral blood flow, flexibility of red blood cell membranes, microcirculation, and tissue oxygenation and reduces viscosity of blood.
Placebo
Placebo tablets
Tocopherol
Tocopherol (vitamin E) impairs tissue fibrosis and is a potent oxygen radical scavenger that may reduce damage caused by free radicals impacting necrosis.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States University of Alabama at Birmingham Birmingham Alabama
United States New York Center for Orthognathic and Maxillofacial Surgery Lake Success New York
United States University of Washington Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
University of Washington New York Center for Orthognathic and Maxillofacial Surgery, University of Alabama at Birmingham, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (8)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in Bone exposure area (mm^2) The primary lesion's area of exposed bone will be estimated by measuring the greatest anterior-posterior and superior-inferior dimensions in millimeters (mm) of the site with the largest area of exposed bone present at the time of study enrollment.
If there are multiple areas of exposed bone in a single patient, the site with the largest sum of linear anterior-posterior and superior-inferior dimensions will be included in the study.
0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Secondary Change in MRONJ Stage MRONJ staging based on AAOMS Position paper staging criteria (Stage 0,1,2,3) 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Secondary Change in Pain Visual analogue scale (VAS) measure of pain. A 100 mm scale will be used with 0 = no pain and 100 = worst pain ever. The patient will be asked to indicate their level of on the VAS. 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Secondary Change in osseous anterior-posterior linear dimension on orthopantomogram Radiographic analysis. Greatest anterior-posterior linear dimension of osseous changes. A 5mm ball bearing will be used to standardize the measurement. 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Secondary Change in osseous superior-inferior linear dimension on orthopantomogram Radiographic analysis. Dsi= Greatest superior-inferior linear dimension of osseous changes. A 5mm ball bearing will be used to standardize the measurement. 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
Secondary Change in osseous area on orthopantomogram Radiographic analysis. Change in area of osseous change. Will be according to the above formulae for shape; rectangle, circle, ellipse for the orthopantomogram imaging. A 5mm ball bearing will be used to standardize the measurement. 0 months, 1 month, 3 months, 6 months, 9 months, 12 months
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