Observational Study of Dental Outcomes in Head and Neck Cancer Patients

This is a prospective cohort study to document dental and other oral outcomes in patients who
receive external beam radiation therapy with curative intent, as part of clinical care for a
head and neck cancer. Five hundred and seventy-five participants will be enrolled. All study
participants will receive a baseline oral examination prior to the start of radiation
therapy. Follow-up examinations and data collection will be conducted at six-month intervals
up to 2 years after the start of radiation therapy. The primary outcome will be the two-year
rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal
health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the
sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current
guidelines and to design future studies on the dental management of these patients.

Inclusion Criteria:

- Aged 18 years and older;

- Willing and able to provide signed and dated consent form;

- 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 subject 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;

- At least 1 natural tooth remaining or expected to remain in the mouth after completion
of the pre-RT dental extractions, if any;

- Willing to comply with all study procedures;

- Willing to participate for the duration of the study.

Exclusion Criteria:

- Receiving palliative RT;

- History of prior curative RT to the head and neck region to eradicate a malignancy;

- Incarcerated at time of screening;

- Anything that would place the subject at increased risk or preclude the subject's full
compliance with or completion of the study.