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

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 1, 2018

Primary Completion Date

January 1, 2026

Study Completion Date

June 30, 2026

Conditions
Medication-related Osteonecrosis of the JawBisphosphonate-related Osteonecrosis of the JawAvascular Necrosis
Interventions
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.

DRUG

Placebo

Placebo tablets

DRUG

Tocopherol

Tocopherol (vitamin E) impairs tissue fibrosis and is a potent oxygen radical scavenger that may reduce damage caused by free radicals impacting necrosis.

Trial Locations (4)

11042

New York Center for Orthognathic and Maxillofacial Surgery, Lake Success

35242

University of Alabama at Birmingham, Birmingham

98195

University of Washington, Seattle

48109-0018

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

University of Alabama at Birmingham

OTHER

collaborator

New York Center for Orthognathic and Maxillofacial Surgery

UNKNOWN

collaborator

University of Michigan

OTHER

lead

University of Washington

OTHER