Intensive Preventative Dental Program Pilot Study (IPDP)

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.

Study Overview

• Status: Completed
• Conditions: Dental Diseases
• Intervention / Treatment: Drug: Fluoride varnish; Other: Regular Care; Other: Medical Oncology Care Team

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Levine Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Preventative Dental Program; head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments.	Drug: Fluoride varnish; fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart
Active Comparator: Regular Care; control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program.	Other: Regular Care; standard oncology assessment visit without Intensive Preventative Dental Program services
Experimental: Medical Oncology Team Providers; Medical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program.	Other: Medical Oncology Care Team; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Decayed, Missing and Filled Surfaces Score	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.	from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Tooth Loss	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.	from baseline to 12 months
Rate of Oral Hygiene Compliance	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.	from baseline to 12 months
Rate of Fluoride Compliance	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.	from baseline to 12 months
Rate of Routine/Preventative Dental Care	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.	from baseline to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Oncology Care Team Post-study Feasibility Survey	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.	12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michael T Brennan, DDS, MHS, Atrium Health Wake Forest University Charlotte Medical Center; Principal Investigator: Matthew C. Ward, MD, Atrium Health Levine Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: October 15, 2025
• First Submitted That Met QC Criteria: October 15, 2025
• First Posted (Estimated): October 17, 2025

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: prevention; head and neck cancer; Osteoradionecrosis; dental caries; dental infection; dental disease; Intensive Preventative Dental Program; Fluoride Varnishes
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Neoplasms; Tooth Diseases; Radiation Injuries; Tooth Demineralization; Head and Neck Neoplasms; Dental Caries; Osteoradionecrosis; Stomatognathic Diseases
• Other Study ID Numbers: IRB00082720; 03-21-01A (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As this is a pilot study which forms the basis of a larger clinical trial, individual deidentified participant data will be shared upon reasonable request to the primary investigators, along with a data dictionary outlining variables collected and data collection forms when appropriate.
• IPD Sharing Time Frame: IPD will be available December 1, 2025 until at least December 1, 2030.
• IPD Sharing Access Criteria: Individual deidentified participant data as outlined above will be shared upon reasonable request to the primary investigators until the conclusion of the follow-up study (approximately December 2030)
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No