Dental Diseases
Conditions
Keywords
Intensive Preventative Dental Program, dental caries, dental disease, prevention, head and neck cancer, Fluoride Varnishes, Osteoradionecrosis, dental infection
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.
Interventions
DRUGFluoride varnish
fluoride varnish placed on teeth by a trained healthcare provider at four visits three months apart
OTHERRegular Care
standard oncology assessment visit without Intensive Preventative Dental Program services
OTHERMedical 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
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decayed, Missing and Filled Surfaces Score | from baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Tooth Loss | from baseline to 12 months | 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. |
| Rate of Oral Hygiene Compliance | from baseline to 12 months | 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. |
| Rate of Fluoride Compliance | from baseline to 12 months | 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. |
| Rate of Routine/Preventative Dental Care | from baseline to 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical Oncology Care Team Post-study Feasibility Survey | 12 months | 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. |
Countries
United States
Outcome results
None listed