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Intensive Preventative Dental Program Pilot Study

NCT07218068 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-11-03

No results posted yet for this study

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

Interventions

DRUG

Fluoride varnish

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

OTHER

Regular Care

standard oncology assessment visit without Intensive Preventative Dental Program services

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Michael T Brennan, DDS, MHS · Atrium Health Wake Forest University Charlotte Medical Center

  • Matthew C. Ward, MD · Atrium Health Levine Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2024-07-10
Completion
2024-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218068 on ClinicalTrials.gov