NCT02057510

Observational Study of Dental Outcomes in Head and Neck Cancer Patients

Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 575 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Head and Neck Cancer
• Dental Disease
• Xerostomia
• Osteoradionecrosis

Timeline

• Start date: 2014-02-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2014-02-07
• Last updated: 2025-07-01

Locations

6 sites across 1 country: United States