NCT05325970

Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients

Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients (ORARAD II)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

Detailed description

This is a prospective cohort study to document long-term dental and other oral outcomes in patients who receive external beam and modern radiation therapy (RT) modalities with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-two participants were enrolled in the original study, ORARAD, which included a baseline oral examination prior to the start of radiation therapy and follow-up examinations and data collection at six-month intervals up to 2 years after the start of RT. The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

Conditions

• Head and Neck Cancer
• Dental Diseases
• Osteoradionecrosis

Timeline

• Start date: 2014-02-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-04-13
• Last updated: 2026-02-06

Locations

6 sites across 1 country: United States