Intensive Preventative Dental Program Pilot Study

NCT07218068 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: IRB0008272003-21-01A
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Diseases

Keywords

Intensive Preventative Dental Program; dental caries; dental disease; prevention; head and neck cancer; Fluoride Varnishes; Osteoradionecrosis; dental infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of Tooth Loss

  from baseline to 12 months

• Rate of Oral Hygiene Compliance

  from baseline to 12 months

• Rate of Fluoride Compliance

  from baseline to 12 months

• Rate of Routine/Preventative Dental Care

  from baseline to 12 months

Other Outcomes (1)

• Medical Oncology Care Team Post-study Feasibility Survey

  12 months

Study Arms (3)

Intensive Preventative Dental Program

EXPERIMENTAL

head and neck cancer patients receive fluoride varnish applied to teeth and follow-up dental screening during regularly scheduled oncology appointments.

Drug: Fluoride varnish

Regular Care

ACTIVE COMPARATOR

control group consisting of head and neck cancer patients receiving regular care of no Intensive Preventative Dental Program.

Other: Regular Care

Medical Oncology Team Providers

EXPERIMENTAL

Medical Oncology care team members (MD, DO, PA, NP, RN) who participate in Intensive Preventative Dental Program.

Other: Medical Oncology Care Team

Interventions

Fluoride varnish DRUG

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

Intensive Preventative Dental Program

Regular Care OTHER

standard oncology assessment visit without Intensive Preventative Dental Program services

Regular Care

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.

Medical Oncology Team Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Stomatognathic Diseases; Dental Caries; Head and Neck Neoplasms; Osteoradionecrosis

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Neoplasms by Site; Neoplasms; Radiation Injuries; Wounds and Injuries

Study Officials

• Michael T Brennan, DDS, MHS

  Atrium Health Wake Forest University Charlotte Medical Center

  PRINCIPAL INVESTIGATOR

• Matthew C. Ward, MD

  Atrium Health Levine Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: October 19, 2021
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: November 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: IPD will be available December 1, 2025 until at least December 1, 2030.
• 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)

Locations

US (1)