Osteonecrosis of jaw Trials in Disease

Study on the Effects of Pentoxifylline, Retinol Acetate, and DL-Alpha Tocopherol Acetate for Patients with Medication-Related Osteonecrosis of the Jaw

This trial is investigating a treatment approach for medication-related osteonecrosis of the jaw (MRONJ), a condition where jawbone tissue dies in patients who have taken certain bone-related medications or cancer treatments. The condition typically causes pain, swelling, infection of the gums, and exposed bone in the mouth, which can make eating, speaking, and maintaining oral hygiene difficult.

Who can participate:

• Adults aged 18 years or older
• Patients currently taking or who have previously taken bisphosphonates (medications that prevent bone damage) either orally or through IV, and/or targeted therapies such as denosumab or bevacizumab
• Those who have experienced signs and symptoms for more than 8 weeks, confirmed not to be caused by dental problems
• Patients diagnosed with AAOMS Stage 2 MRONJ, which is a specific stage of the condition
• Patients of childbearing age must use effective contraception

Who cannot participate:

• Patients who fall outside the specified age range
• Those considered part of a vulnerable population requiring special protection or care
• Individuals who do not meet the specific diagnostic criteria for the condition being studied

What the trial involves:

The study focuses on testing a treatment protocol called PENTO, which combines several medications taken by mouth: pentoxifylline, retinol acetate (Vitamin A acetate), and dl-alpha tocopherol acetate (Vitamin E). Participants will also receive clindamycin hydrochloride and amoxicillin sodium with clavulanic acid as part of the treatment regimen.

The main goal is to assess whether the PENTO treatment can help heal the jawbone over 12 months. Success is defined as reducing the area of exposed bone in the jaw to less than 5 millimeters. The treatment works by promoting bone healing and reducing inflammation in the affected area.

Participants will attend follow-up visits at 1, 3, 6, and 12 months after starting treatment. During these visits, doctors will measure the exposed bone area, assess nutritional parameters including weight, body mass index (BMI), and blood protein levels that indicate nutrition status. They will also use a modified SOMA score to evaluate symptoms and track any side effects or adverse events.

At the initial assessment, baseline measurements are taken to establish the starting condition. Throughout the trial, careful monitoring ensures patient safety and helps researchers understand how well the treatment is working. The final assessment at 12 months will determine how many patients achieved significant healing.