Fluoride Varnish for Head and Neck Cancer

AC
Overseen ByAlyssa Civantos, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of fluoride varnish to protect teeth in individuals who have undergone head and neck cancer treatments. Researchers aim to determine if this dental treatment can be conveniently administered during regular cancer check-ups, particularly for those with limited access to dental care. Individuals who have received radiation for head and neck cancer and face challenges in obtaining dental care may be suitable candidates for this trial. Participants will receive fluoride varnish treatments and provide feedback through surveys and saliva samples. As an unphased trial, this study offers a unique opportunity to contribute to research that may enhance dental care accessibility for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that fluoride varnish treatment is safe for post-radiation head and neck cancer patients?

Research has shown that fluoride varnish treatments are generally safe for dental care. One important study found that 99% of patients continued with the treatment for up to six months, indicating tolerability. Another study confirmed that sodium fluoride, the main ingredient in the varnish, does not cause cancer. While some studies have raised concerns about fluoride, using it occasionally in professional settings like this trial is unlikely to cause serious side effects.

The specific product used in this trial, Duraflor Ultra 5% Sodium Fluoride Varnish, is easy to apply and adheres well to teeth, providing benefits with little discomfort. Some patients may notice reduced tooth sensitivity over time; in one study, sensitivity decreased from 39% to 25% over 15 months. Overall, these findings suggest that fluoride varnish treatments are well-tolerated with few negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about fluoride varnish treatments for head and neck cancer patients because it offers a targeted approach to protect teeth during cancer treatment. Unlike typical dental care options, which might include fluoride toothpaste or mouth rinses, this varnish is applied directly to the teeth, providing a high concentration of fluoride that adheres to the enamel longer. This method is particularly promising because it can be conveniently integrated into routine cancer surveillance visits, potentially improving dental health without adding extra appointments for patients already managing a heavy treatment schedule.

What evidence suggests that fluoride varnish treatment might be an effective treatment for head and neck cancer patients?

Research has shown that fluoride varnish reduces tooth sensitivity and prevents cavities. For instance, one study found that tooth sensitivity in patients decreased from 39% to 25% over 15 months with varnish use. The varnish releases fluoride, strengthening teeth and preventing decay. Studies indicate that fluoride varnish can reduce cavities by 50 to 70%. In this trial, participants will receive fluoride varnish treatments during their routine cancer surveillance visits. This is especially beneficial for individuals who have undergone radiation treatment for head and neck cancer, as they often face a higher risk of dental problems.16789

Who Is on the Research Team?

MJ

Mary J Xu, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had radiation for head and neck cancer and have limited or no dental insurance. Participants must be able to give written consent.

Inclusion Criteria

I am over 18 and have no insurance, limited insurance, or full coverage.
I have received immunotherapy or strong chemotherapy treatments.
I am able to understand and sign a consent form myself.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fluoride varnish treatments during routine cancer surveillance visits

1 year
Visits every 3-6 months

Follow-up

Participants are monitored for changes in oral health and knowledge after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fluoride Varnish Treatment

Trial Overview

The study looks at whether giving fluoride varnish treatments during regular cancer check-ups helps improve oral health in patients after radiation. It also uses surveys, saliva samples, photos, and interviews to gather information.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: InterviewExperimental Treatment1 Intervention
Group II: Fluoride Varnish Treatment (Participant)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Effectiveness of Fluoride Varnish Application as Cariostatic ...

Dental sensitivity decreased from 39% at 3 months to 25% at 15 months followup. 99% compliance to fluoride varnish application was seen till six months followup ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23843793/

Effectiveness of fluoride varnish application as cariostatic ...

Dental sensitivity decreased from 39% at 3 months to 25% at 15 months followup. 99% compliance to fluoride varnish application was seen till six months followup ...

Post-Radiation Oral Health in Underserved Head and Neck ...

This is a pilot study evaluates the feasibility and outcomes of providing fluoride varnish treatment during routine cancer surveillance ...

(PDF) Effectiveness of Fluoride Varnish Application as ...

Dental sensitivity decreased from 39% at 3 months to 25% at 15 months followup. 99% compliance to fluoride varnish application was seen till six months followup ...

Duraflor® Ultra™ 5% Sodium Fluoride White Varnish by ...

Ultra's advanced formula is designed to quickly release fluoride within 2 hours to 4 hours, so patients get the maximum fluoride benefit while ...

SAFETY DATA SHEET

Repeated overexposure to Sodium Fluoride may cause fluorosis. Mutagenicity: N/A. Carcinogenicity: Not known to be as carcinogen or potential carcinogen by NTP ( ...

6 Dangers of Fluoride Treatments (And What to Do Instead)

Fluoride may be linked to certain cancers. Fluoride treatments seem to pose little risk of cancer due to the infrequency of professional dental ...

Duraflor® Ultra™ White 5% Sodium Fluoride Varnish - Medicom

Provides our fastest fluoride release over 2, 4 and 24-hours. Smooth consistency ensures easy application. Strong adherence to teeth maximizes benefits and ...

Main Findings and Author's Conclusions - Fluoride Varnishes ...

“The meta-analysis showed that fluoride varnish is an effective approach for arresting the progression of enamel carious lesions in primary and permanent teeth.