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Completed

NCT Number: NCT07218068

Intensive Preventative Dental Program Pilot Study

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.

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Key information

Conditions

Dental Diseases Dental Caries Head and Neck Neoplasms Neoplasms Neoplasms by Site Osteoradionecrosis Radiation Injuries Stomatognathic Diseases Tooth Demineralization Tooth Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

About this study

The overall objective of this clinical trial is to determine if oncology practices can reduce dental disease in head and neck cancer patients post radiation therapy. Participants will have fluoride varnish applied at planned oncology follow-up visits and medical oncology providers will be instructed on recognizing dental disease and referring head and neck cancer patients for dental care when needed.

Who can participate

Healthy volunteers accepted: No

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

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:
  • 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.

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.

Treatment and study plan

Fluoride varnish

Drug

fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart

Regular Care

Other

standard oncology assessment visit without Intensive Preventative Dental Program services

Medical Oncology Care Team

Other

Medical Oncology care team members participating in the Intensive Preventative Dental Program will be guided on recognizing dental disease and when it is appropriate to refer head and neck cancer patients for dental care.

Primary outcomes

  1. Change in Decayed, Missing and Filled Surfaces Score

    Time frame: from baseline to 12 months

    Decayed, Missing and Filled Surfaces Score (DMFS) is calculated by a calibrated oral examiner as the combined number of of decayed, missing, and/or filled tooth surfaces, from the baseline dental visit DMFS score before starting radiotherapy to the final dental visit DMFS score 12 months following completion of radiation therapy.

Secondary outcomes

  1. Rate of Tooth Loss

    Time frame: from baseline to 12 months

    Number of teeth lost per participant as determined by a calculated oral examiner from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.

  2. Rate of Oral Hygiene Compliance

    Time frame: from baseline to 12 months

    Number of participants who self-report daily toothbrushing and flossing from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.

  3. Rate of Fluoride Compliance

    Time frame: from baseline to 12 months

    Number of participants who self-reported use of prescription fluoride daily from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.

  4. Rate of Routine/Preventative Dental Care

    Time frame: from baseline to 12 months

    Number of participants who self-report visiting a dental office within the last six months from the baseline dental visit before the start of radiotherapy to the dental visit 12 months after completing radiation therapy.

Other outcomes

  1. Medical Oncology Care Team Post-study Feasibility Survey

    Time frame: 12 months

    The feasibility survey evaluates the logistics and success in implementing the Intensive Preventative Dental Program for Medical Oncology Team Providers treating head and neck cancer patients by gathering feedback from the Medical Oncology Care Team. Items are scored with 1-5 point Likert scale with a lower scale indicating higher satisfaction with the intervention.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: IPDP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2025
Registry last updated
Nov 3, 2025

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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