HARVARD SCHOOL OF DENTAL MEDICINE

FDA-Cleared Chemo Mouthpiece Reduces Oral Pain by 46% and Opioid Use by 68% in Pivotal Cancer Trial

- The Chemo Mouthpiece, an FDA 510(k) cleared intraoral cryotherapy device, demonstrated a 46% reduction in patient-reported oral pain and 68% reduction in opioid or analgesic use during chemotherapy in a multi-center randomized controlled trial. - The pivotal study enrolled 164 patients across 16 U.S. sites and showed efficacy across more than 30 chemotherapy regimens and 17 cancer types, with 83% of patients indicating they would recommend the device. - Published in Supportive Care in Cancer, the trial results validate the device as a safe and effective alternative to traditional ice chip cryotherapy for managing oral mucositis, a painful side effect affecting up to 80% of chemotherapy patients.