Spots Global Cancer Trial Database for Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients

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Trial Identification

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

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

Study ID: NCT05325970

Conditions

Head and Neck Cancer

Dental Diseases

Osteoradionecrosis

Interventions

Study Description

Brief 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.