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

May 28, 2026 updated by: University of California, San Francisco
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean score of Feasibility of Intervention Measure (FIM)
Time Frame: Up to 1 year
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
Time Frame: Up to one day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change of Score of Dental Care Practice
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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)
Time Frame: Up to 1 year
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
Time Frame: Up to 1 year
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary J Xu, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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