Recruitment

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