NCT07218068

Intensive Preventative Dental Program Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Dental Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-07-10
• Completion: 2024-07-10
• First posted: 2025-10-20
• Last updated: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study