Observational Study of Dental Outcomes in Head and Neck Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 756
Summary
- Conditions
- Dental Disease
- Head and Neck Cancer
- Osteoradionecrosis
- Xerostomia
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 re...
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.
Tracking Information
- NCT #
- NCT02057510
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- University of Minnesota
- UConn Health
- University of Pennsylvania
- Brigham and Women's Hospital
- NYU Langone Health
- University of North Carolina
- Investigators
- Study Chair: Michael T Brennan, DDS, MHS Atrium Health Study Chair: Rajesh Lalla, DDS, PhD University of Connecticut Health Center - School of Dental Medicine