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

PROJECT ABSTRACT
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.

Grant Number: 1UG3DE035104-01
NIH Institute/Center: NIH
Principal Investigator: MICHAEL BRENNAN