Effectiveness of an Early Intensive Preventive Dental Program by Oncology Providers to Reduce Dental Disease and Improve Compliance in Head and Neck Cancer Patients: OraRad IPDP

Radiation therapy for head and neck cancer significantly increases the risk for hyposalivation, dental caries, gingival recession, trismus, tooth loss, and osteoradionecrosis, contributing to a well-documented decline in oral health-related quality of life (OH-QOL) after radiation therapy for head and neck cancer. A major contributor to this decline in oral and dental health and in OH-QOL is the unusually rapid progression of dental caries. Although topical fluoride can reduce caries progression, compliance with homecare and with preventive professional dental care is low in the head and neck cancer population. To address this problem, we propose to test an innovative intervention in a setting with known high compliance, the oncology office. This clinical trial's overall objective is to determine if an Intensive Preventive Dental Program administered in an oncology practice can reduce dental disease in patients with head and neck cancer post-radiation therapy compared to current oncology care practice that occurs post radiation therapy. The feasibility of this prevention program has been established by a pilot study of this intervention and by our completed OraRad study, which enrolled 572 patients with head and neck cancer across our 6 U.S. clinical sites. The Intensive Preventive Dental Program includes 1) application of fluoride varnish by a medical team member during routinely scheduled post-RT oncology follow-up visits and 2) recognition and dental referral for patients with signs and symptoms of dental disease or poor compliance with preventive professional dental care. Our primary hypothesis is that a preventive dental program in oncology offices will improve oral health outcomes and improve oral health follow- up for this high-risk group of patients. We will test this hypothesis by conducting a randomized clinical trial to accomplish these Specific Aims: determine the impact of an Intensive Preventive Dental Program on 1) dental caries progression (decayed, missing and filled surfaces- DMFS, primary outcome); 2) tooth loss and oral health-related quality of life (secondary outcomes); 3) homecare compliance and compliance with receiving preventive professional dental care (secondary outcomes). We hypothesize that participants who receive the Intensive Preventive Dental Program will have lower DMFS scores and tooth loss, higher oral health-related quality of life, and increased compliance with homecare and preventive professional dental care, compared to participants who do not receive the Intensive Preventive Dental Program. If effective, these findings could support translation of this intervention across oncology centers nationwide. Our proposed study thus has the potential for high societal impact by further integrating medical and dental care to improve health outcomes. Project Number: 1UG3DE035104-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Dental and Craniofacial Research (NIDCR) | Principal Investigator: MICHAEL BRENNAN (+1 co-PI) | Institution: WAKE FOREST UNIVERSITY HEALTH SCIENCES, WINSTON-SALEM, NC | Award Amount: $681,331 | Activity Code: UG3 | Study Section: Special Emphasis Panel[ZDE1 YM (07)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11202306