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

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.

Medication-related Osteonecrosis of the Jaw

Bisphosphonate-related Osteonecrosis of the Jaw

Avascular Necrosis

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.

Pentoxifylline

Placebo

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

Tocopherol

University of Alabama at Birmingham

University of Michigan

New York Center for Orthognathic and Maxillofacial Surgery

University of Washington

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

Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ): A Prospective, Randomized Controlled Trial to Evaluate a Novel Non-operative Treatment

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.

MRONJ staging based on AAOMS Position paper staging criteria (Stage 0,1,2,3)

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.

Radiographic analysis. Greatest anterior-posterior linear dimension of osseous changes. A 5mm ball bearing will be used to standardize the measurement.

Radiographic analysis. Dsi= Greatest superior-inferior linear dimension of osseous changes. A 5mm ball bearing will be used to standardize the measurement.

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.

Jasjit Dillon

Clinical Assistant Professor & Program Director, Oral & Maxillofacial Surgery

Oregon Health and Science University

Intervention: Twice-daily administration of N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablets

Intervention: Twice daily administration of sham/placebo tablet

Migraine, Headaches

N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet

Effect on Migraine Frequency of Combined Anti-oxidant Therapy: The MIGRANT Study.

Effect on Migraine Frequency of Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC): The MIGRANT Study

Difference in mean number of migraine episodes per month between baseline and final four weeks of the study, for both study groups.

Difference in mean migraine duration (hours) per month between baseline and final four weeks of the study, for both study groups

Difference in mean migraine severity score per month (categorical scale; 0 = nil, 1 = mild, 2 = moderate, 3 = severe) between baseline and final four weeks of the study, for both study groups.

Migraine Disability Assessment Score (MIDAS).

Difference in mean MSQ score per month between baseline and final four weeks of the study, for both study groups. Migraine Specific Quality of Life Questionnaire (MSQ, Version 2.1) score.

Difference in mean HRQOL score per month between baseline and final four weeks of the study, for both study groups.Health Related Quality of Life (HRQOL) score

Number of treatment adverse events per month

Difference in mean number of migraine days per month between baseline and final four weeks of the study, for both study groups.

Responder rate: Percentage of subjects reporting ≥ 30% reduction in migraine episodes per month between baseline and final four weeks of the study, for both study groups

tocopherol/headache

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

Effect on Migraine Frequency of Combined Anti-oxidant Therapy: The MIGRANT Study.

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