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NCT07218068CompletedEarly phase 1

Intensive Preventative Dental Program Pilot Study

Source: ClinicalTrials.gov · Last updated 3 Nov 2025

Brief summary (registry, in English)

Radiation therapy to treat cancer may cause a dry mouth from damage to salivary glands which may increase the risk of cavities on the teeth. The consistent use of prescription fluoride on teeth after radiation therapy for head and neck cancer may reduce the development of cavities and tooth loss. The purpose of this study is to find out if prescription fluoride varnish applied to the teeth every three months during the first year after radiation therapy changes the development of cavities or gum problems.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
13 (actual)
First submitted
15 Oct 2025
Start date
Oct 2021
Primary completion date
Jul 2024
Lead sponsor
Wake Forest University Health Sciences
NCT number
NCT07218068

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 13
  • From Oct 2021 to the primary completion date, Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving palliative RT
  • History of prior curative RT to the head and neck region to eradicate a malignancy.

Other

  • 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.

Who the study is looking for

  • 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:
    • base of tongue
    • buccal/labial mucosa
    • epiglottis
    • floor of mouth
    • gingiva/alveolar ridge
    • hard palate
    • hypopharynx
    • larynx
    • lip
    • mandible
    • maxilla
    • maxillary sinus
    • nasal cavity
    • nasopharynx
    • neck
    • oral cavity
    • oral tongue
    • oropharynx
    • paranasal sinus/orbit
    • parotid gland
    • pharynx
    • retromolar trigone
    • soft palate
    • sublingual gland
    • submandibular gland
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Levine Cancer Institute
Coordinator of this site? Confirm its status		CharlotteUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.