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

Late Radiation Injury

Chronic Pain

University Health Network

HBOT Late Radiation Tissue Injury

Does Hyperbaric Oxygen Therapy (HBOT) Reduce Pain, Improve Depression and Impact on Patients' Quality of Life for Those Suffering From Late Radiation Tissue Injury?

Pain will be assessed with the 11 point numeric rating scale (NRS; 0 = "no pain" to 10 = "unbearable pain").Patients will be asked to document their pain during the previous 24 hours daily upon awakening and immediately after the intervention. Daily and weekly mean pain scores and the proportion of responders, defined as patients with a ≥30% reduction in mean pain score from baseline to endpoint will be recorded.
The Brief Pain Inventory short form will also be administered.

Will be measured using the pain disability index (PDI). The tool is valid and reliable instrument widely used to assess chronic pain patients in research and clinical settings.

Will be assessed with the European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ C30). The EORTC QLQ-C30 is a self administered questionnaire developed to assess the quality of life of cancer patients. It has been translated and validated into 81 languages and is used in more than 3,000 studies worldwide. It is composed of both multi-item scales and single item measures.These include 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties).

The scale has been recommended by Initiatives on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to evaluate the efficacy of treatment in chronic pain trials. It assesses global response to treatment and uses a 7-point Likert scale that varies from 1 (very much improved) to 7 (very much worse).

Depression and anxiety will be assessed with the Hospital Anxiety (HADS-A) and Depression (HADS-D) scale, consisting of 14 items (7 each for anxiety and depression).

University Health Network, Toronto

Open label = Single dose administration of single dose Denosumab 120 mg subcutaneously

Crohn Disease

Denosumab

University of Manitoba

The Efficacy of Denosumab in Active Crohn's Disease

Denosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's Disease

Decrease in CDAI to ≤150 points at 12 weeks.

In those with elevated fecal calprotectin at baseline, reduction in fecal calprotectin to <250 ug/g at week 12.

for those with increased CRP at baseline change in CRP to normal at week 12

For those who underwent endoscopy within 1 month of study enrollment as part of standard of care and who underwent a repeat endoscopy within 1 month of study completion as part of standard of care, improvement in endoscopy by Crohn's Disease Endoscopy Inflammation Score (CDEIS) between baseline and second endoscopy.

For those who underwent abdominal MRI within 1 month of study enrollment as part of standard of care and who underwent a repeat abdominal MRI within 1 month of study completion as part of standard of care then improvement in MRI findings by central reader (Dr H Greenberg) between baseline and second abdominal MRI.

Serum calcium will be assessed at 3 days post drug administration and every 4 weeks. There is a rare incidence of hypocalcemia with use of this drug. Osteonecrosis of the jaw will be assessed at every study visit. This drug is rarely associated with this outcome especially in cancer patients. Liver enzymes every 4 weeks will be assessed.

osteonecrosis/galvassāpes

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

HBOT Late Radiation Tissue Injury

The Efficacy of Denosumab in Active Crohn's Disease

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