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NCT Number: NCT07556367

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Head and Neck Cancer Head and Neck Carcinoma Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, 94110, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >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.

Exclusion criteria

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

Treatment and study plan

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.

Saliva collection

Procedure

Participants will provide a saliva sample for pH measurement.

Intra-oral photographs

Procedure

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

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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