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Fluoride shield: new hope for cancer Patients' teeth

NCT ID NCT07218068

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether applying prescription fluoride varnish to teeth every three months during the first year after radiation therapy for head and neck cancer can reduce cavities and gum problems. 13 adults with at least 4 natural teeth and certain cancers took part. The goal was to see if this simple dental program helps prevent tooth decay and loss caused by dry mouth from radiation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

13 people

The number who actually took part.

Started

Oct 2021

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 years and older * Willing and able to provide signed and dated consent form * Presence of at least 4 natural erupted teeth remaining in the mouth after completion of pre-RT dental management * Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy; OR * Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The participant must be expected to receive at least 4500 cGy to one of the following sites: 1. base of tongue 2. buccal/labial mucosa 3. epiglottis 4. floor of mouth 5. gingiva/alveolar ridge 6. hard palate 7. hypopharynx 8. larynx 9. lip 10. mandible 11. maxilla 12. maxillary sinus 13. nasal cavity 14. nasopharynx 15. neck 16. oral cavity 17. oral tongue 18. oropharynx 19. paranasal sinus/orbit 20. parotid gland 21. pharynx 22. retromolar trigone 23. soft palate 24. sublingual gland 25. submandibular gland 26. tonsil; * Willing to comply with all study procedures * Willing to participate for the duration of the study * RT follow-up planned for one of the selected AH Oncology Specialist Follow-up Sites. Exclusion Criteria: * Receiving palliative RT * History of prior curative RT to the head and neck region to eradicate a malignancy. * Incarcerated at the time of screening * Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma osteoradionecrosis salivary gland cancer Stomatognathic Diseases dental caries prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dental diseases

Contacts and locations

Locations

  • Levine Cancer Institute

    Charlotte, North Carolina, 28203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.