Head and Neck CancerNCT07556367
Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients
A study testing Surveys, Saliva Collection and Intra-oral photographs in people with Head and Neck Cancer and Head and Neck Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Carcinoma, Head and Neck Neoplasms
- What is being tested?
- Surveys, Saliva Collection and Intra-oral photographs
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- >18 years old.
- Patients, caregivers, health and dental care providers who are able to provide their own informed written consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, 94110
About this study
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.
Read the 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:
- 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
- Being tested
- Surveys, Saliva Collection, Intra-oral photographs, Fluoride Varnish Treatment, Interview (Participant)
- Keywords
- Oral health, Fluoride varnish, Dental care, Radiation therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
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 CollectionProcedure or surgery
Participants will provide a saliva sample for pH measurement.
Intra-oral photographsProcedure or surgery
Images of participants' teeth will be taken to assess the Decayed, Missing, and Filled Teeth (DMFT) index.
Fluoride Varnish TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Interview (Participant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to one day
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Oct 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary J Xu, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556367
- Sponsor's protocol ID
- 242010
- Other IDs
- NCI-2026-02914
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Radiation Oral Health in Underserved Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT07556367
- Acronym / sponsor ID
- 242010
- Keywords
- Oral health, Fluoride varnish, Dental care, Radiation therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish Treatment (Participant) | Experimental | Other: Surveys, Procedure: Saliva Collection, Procedure: Intra-oral photographs, Device: Fluoride Varnish TreatmentParticipants 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. |
| Interview | Other | Other: Interview (Participant)The research team will interviews with participants, caregivers, and healthcare and dental providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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.
Key exclusion criteria (2 listed)
- >18 years old.
- Patients, caregivers, health and dental care providers who are able to provide their own informed written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysParticipants 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. | Other | Fluoride Varnish Treatment (Participant) |
| Saliva CollectionParticipants will provide a saliva sample for pH measurement. | Procedure or surgery | Fluoride Varnish Treatment (Participant) |
| Intra-oral photographsImages of participants' teeth will be taken to assess the Decayed, Missing, and Filled Teeth (DMFT) index. | Procedure or surgery | Fluoride Varnish Treatment (Participant) |
| Fluoride Varnish TreatmentParticipants 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. | Device | Fluoride Varnish Treatment (Participant) |
| 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. | Other | Interview |
Primary outcome
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.
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.
5 secondary outcomes
Mean Change of Score of Dental Care Practice
Time frame: Up to 1 year
Mean Change of Score of Familiarity with the Risks of Radiation
Time frame: Up to 1 year
Change in Saliva potential hydrogen (pH) measure
Time frame: Up to 1 year
Mean Change of Score of Oral Health-Related Quality of Life (OHRQoL)
Time frame: Up to 1 year
Mean score Change in Decayed-Missing-Filled Teeth (DMFT) Index
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary J Xu, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys, Saliva Collection and Intra-oral photographs in people with Head and Neck Cancer and Head and Neck Carcinoma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score of Feasibility of Intervention Measure (FIM) (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.