Observational Study of Dental Outcomes in Head and Neck Cancer Patients



Status:Active, not recruiting
Conditions:Cancer, Cancer, Other Indications, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:7/25/2018
Start Date:February 2014
End Date:November 2020

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Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

The purpose of this study is to measure the two-year rate of tooth loss in patients who have
received external beam radiation therapy with curative intent for head and neck cancer. The
study will also evaluate the sequelae of radiation therapy and oral complications that may
occur as a result to receiving radiation therapy.

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.
We found this trial at
6
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Nathaniel Treister, DMD
Phone: 617-732-6813
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chapel Hill, North Carolina 27599
Principal Investigator: Lauren Patton, DDS
Phone: 919-537-3361
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Charlotte, North Carolina 28203
Principal Investigator: Michael Brennan, DDS, MHS
Phone: 704-355-0174
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Farmington, Connecticut 06030
Principal Investigator: Rajesh Lalla, DDS, PhD
Phone: 860-679-3918
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New York, New York 10019
Principal Investigator: Brian Schmidt, DDS, MD, PhD
Phone: 212-998-9202
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Philadelphia, Pennsylvania 19104
Principal Investigator: Thomas Sollecito, DDS
Phone: 215-349-5409
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Philadelphia, PA
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