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

NCT07556367 | Recruiting DMC FDA Device

• 2 other identifiers: 242010NCI-2026-02914
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Carcinoma; Head and Neck Neoplasms; Head and Neck Cancer

Keywords

Oral health; Fluoride varnish; Dental care; Radiation therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Mean Change of Score of Dental Care Practice

  Up to 1 year

• Mean Change of Score of Familiarity with the Risks of Radiation

  Up to 1 year

• Change in Saliva potential hydrogen (pH) measure

  Up to 1 year

• Mean Change of Score of Oral Health-Related Quality of Life (OHRQoL)

  Up to 1 year

• Mean score Change in Decayed-Missing-Filled Teeth (DMFT) Index

  Up to 1 year

Study Arms (2)

Fluoride Varnish Treatment (Participant)

EXPERIMENTAL

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; Procedure: Saliva Collection; Procedure: Intra-oral photographs; Device: Fluoride Varnish Treatment

Interview

OTHER

The research team will interviews with participants, caregivers, and healthcare and dental providers.

Other: Interview (Participant)

Interventions

Surveys OTHER

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.

Fluoride Varnish Treatment (Participant)

Saliva Collection PROCEDURE

Participants will provide a saliva sample for pH measurement.

Fluoride Varnish Treatment (Participant)

Intra-oral photographs PROCEDURE

Images of participants' teeth will be taken to assess the Decayed, Missing, and Filled Teeth (DMFT) index.

Fluoride Varnish Treatment (Participant)

Fluoride Varnish Treatment DEVICE

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.

Fluoride Varnish Treatment (Participant)

Interview (Participant) OTHER

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.

Interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mary J Xu, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa Civantos, MD

CONTACT

877-827-3222; alyssa.civantos@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)