Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients

This is a pilot study evaluates the feasibility and outcomes of providing fluoride varnish treatment during routine cancer surveillance visits for post-radiation head and neck cancer patients with limited access to dental care.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Head and Neck Carcinoma
• Intervention / Treatment: Other: Surveys; Procedure: Saliva Collection; Procedure: Intra-oral photographs; Device: Fluoride Varnish Treatment; Other: Interview (Participant)

Detailed Description

PRIMARY OBJECTIVES:

I.To describe the baseline knowledge and access to dental care of underinsured/uninsured head and neck cancer patients treated with radiation at University California of San Francisco (UCSF) and Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG).

II.To pilot and characterize the feasibility and outcomes of an in-clinic fluoride varnish dental treatment paired with routine cancer surveillance for post-radiation head and neck cancer patients who do not have reliable access to dental care

III.To develop readily accessible patient educational material for dental care after radiation treatment for HNC.

SECONDARY OBJECTIVES:

I. Explore barriers and facilitators to adapting an integrated preventative fluoride intervention into clinical care for HNC patients through qualitative interviews.

II. Co-design patient advocacy materials and a clinician implementation toolkit to provide a framework for adopting this intervention diverse community-based settings

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Zuckerberg San Francisco General Hospital (ZSFG)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. >18 years old who are uninsured or underinsured (MediCal, Healthy SF) or have full coverage.
2. Patients who have received immunotherapy or enhanced chemotherapy regimens.
3. Patients or health and dental care providers who are able to provide their own informed written consent.

Exclusion Criteria:

1. >18 years old.
2. Patients, caregivers, health and dental care providers who are able to provide their own informed written consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoride Varnish Treatment (Participant); Participants will received Medicom Duraflor Ultra White 5% Sodium Fluoride varnish treatments during their routine cancer surveillance visits every 3-6 month for about 1 year. During these visits, participants will complete short surveys, provide saliva samples, and have photos taken of their teeth before and after the treatment. Health and dental care providers will also be asked to complete a survey about fluoride treatment delivered.	Other: Surveys; Participants will complete surveys to collect information about their dental health before and after fluoride varnish treatment. Healthcare and dental providers will complete a survey to assess the feasibility of the fluoride varnish treatment.; Procedure: Saliva Collection; Participants will provide a saliva sample for pH measurement.; Procedure: Intra-oral photographs; Images of participants' teeth will be taken to assess the Decayed, Missing, and Filled Teeth (DMFT) index.; Device: Fluoride Varnish Treatment; Participants will receive 4-5 fluoride varnish treatment every 3 month over the course of a year. Treatment is delivered during cancer surveillance visits. Participant will also receive dental care educational materials.
Other: Interview; The research team will interviews with participants, caregivers, and healthcare and dental providers.	Other: Interview (Participant); Participants and caregivers will share their experiences accessing dental care, identify barriers to care, and provide their views on integrating preventive dental care into routine medical care. Healthcare and dental providers will share their observations about patient access to dental care and their views on integrating preventive dental care into routine medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean score of Feasibility of Intervention Measure (FIM)	The Feasibility of Intervention Measure (FIM) is a 4-item implementation measure that assesses participants or providers' perceived feasibility of the intervention. Responses are rated on a 5-point Likert scale ranging from 1 (Completely Disagree) to 5 (Completely Agree). The survey is administered at baseline and at each surveillance visit.	Up to 1 year
Interview	Interview will be conducted with participants and providers using guided questions. Responses will be analyzed to assess the feasibility and potential for expanding the fluoride varnish program.	Up to one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change of Score of Dental Care Practice	The Dental Care Practices Survey assesses oral health behaviors and dental care utilization, including frequency of dental visits, toothbrushing tools, and flossing practices. Mean changes in survey scores will be evaluated to assess changes in dental care practices following fluoride varnish treatment and dental health education. Participants will complete the survey at baseline and at each surveillance visit.	Up to 1 year
Mean Change of Score of Familiarity with the Risks of Radiation	The Familiarity with the Risks of Radiation Survey assesses knowledge of the effects of head and neck radiation on oral health and attitudes toward seeking dental care. Mean changes in survey scores will be evaluated to assess changes in knowledge and attitudes following fluoride varnish treatment and dental health education. Participants will complete the survey at baseline and at each surveillance visit.	Up to 1 year
Change in Saliva potential hydrogen (pH) measure	Changes in salivary potential hydrogen (pH) will be evaluated to assess changes in oral health status following fluoride varnish treatment and dental health education. Saliva samples will be collected from participants at baseline and at each surveillance visit, and pH will be measured using a digital pH meter.	Up to 1 year
Mean Change of Score of Oral Health-Related Quality of Life (OHRQoL)	Participants will complete the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life (OHRQoL). The OHIP-14 is a 14-item questionnaire that measures OHRQoL across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses are rated on a 5-point Likert scale ranging from 0 (Never) to 5 (Always). Mean changes in OHRQoL scores will be used to evaluate changes following fluoride varnish treatment and dental health education. The questionnaire will be completed at baseline and at each surveillance visit.	Up to 1 year
Mean score Change in Decayed-Missing-Filled Teeth (DMFT) Index	The Decayed, Missing, and Filled Teeth (DMFT) index is measured as the number of decayed, missing, and filled teeth. Mean changes in DMFT scores will be used to evaluate changes in oral health following fluoride varnish treatment and dental health education. The DMFT assessment will be performed at baseline and at each surveillance visit.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Mary J Xu, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Radiation therapy; Fluoride varnish; Oral health; Dental care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Surveys and Questionnaires
• Other Study ID Numbers: 242010; NCI-2026-02914 (Registry Identifier: NCI Clinical Trials Reporting System (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes