Intensive Preventative Dental Program Pilot Study

NCT ID: NCT07218068

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2024-07-10

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluoride varnish

Intervention Type: DRUG

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

Regular Care

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

Group Type: ACTIVE_COMPARATOR

Regular Care

Intervention Type: OTHER

standard oncology assessment visit without Intensive Preventative Dental Program services

Medical Oncology Team Providers

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

Group Type: EXPERIMENTAL

Medical Oncology Care Team

Intervention Type: 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.

Interventions

Fluoride varnish

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

Intervention Type: DRUG

Regular Care

standard oncology assessment visit without Intensive Preventative Dental Program services

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael T Brennan, DDS, MHS

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest University Charlotte Medical Center

Matthew C. Ward, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Levine Cancer Center

Locations

Levine Cancer Institute

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

03-21-01A

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082720

Identifier Type: -

Identifier Source: org_study_id