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

Active, not recruiting

• Conditions: Head and Neck Cancer; Dental Diseases; Osteoradionecrosis

• Registration Number: NCT05325970
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Enrolled in the original ORARAD study
• Willing to participate and comply with all study procedures

Exclusion Criteria

• Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study (e.g., unable to obtain consent or unable to tolerate an oral examination).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exposed intraoral bone	7 years	Exposed intraoral bone is documented clinically by a trained clinical examiner and assessed based on a visual examination of the area, documenting the related tooth numbers or area and the following clinical signs: pain, swelling, induration, sequestrum, thin skin and/or beard loss (i.e. tissue hypoxia), evidence of pathologic fracture, tooth mobility, altered sensation in the affected area. The percentage of patients experiencing exposed bone, their recovery rates, and percent experiencing the signs will be calculated.
Dental Caries	7 years	Dental caries will be ascertained through the examination parameters outlined by NHANES, and the results of this examination with be used to calculate DMFS scores.
Pocket depth (Periodontal Measure 3)	7 years	Pocket depth measured in mm
Bleeding on probing is documented (yes/no) (Periodontal Measure 1)	7 years	Bleeding on probing is documented (yes/no) and a percentage of "yes" responses will be calculated.
Clinical attachment loss (CAL) (Periodontal Measure 2)	7 years	Clinical attachment loss (CAL) measured in mm
Tooth Loss	7 years	"Tooth loss" will be defined as a dental extraction that has been performed or recommended. Change in number of teeth throughout the duration of the study will be documented.
Salivary flow	7 years	Salivary flow is measured by the whole stimulated salivary flow rate. Changes in the rate and any association with other outcomes (e.g., caries) will be calculated.

Secondary Outcome Measures

Name	Time	Method
Compliance with brushing/flossing	7 years	Patients complete a questionnaire on frequency of brushing and flossing. Percent compliance with brushing and flossing guidelines (2x per day according to evidence-based professional guidelines) and change in compliance will be calculated.
Changes in RT-specific quality of life measures	7 years	Patients complete a likert scale questionnaire on 10 quality of life measures based on the European Organization for Research and Treatment of Cancer questionnaire. Ten individual question items were scored on a four-point scale indicating level of difficulty with daily tasks (1=not at all; 2=a little; 3=quite a bit; 4=very much).
Mortality	7 years
Cancer recurrence	7 years
Trismus measurements in mm	7 years	Change in mouth opening are documented in mm
7-year use of fluoride	7 years	Patients complete a questionnaire on use of fluoride (other than over the counter toothpaste), type, and frequency. Percent compliance with fluoride use and change in fluoride use will be calculated.
Change in pain scores	7 years	Patients complete a likert scale questionnaire on pain levels during 8 daily activities rating their pain from no pain (0) to the worst pain imaginable (5) based on the European Organization for Research and Treatment of Cancer questionnaire.

Trial Locations

Locations (6)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Connecticut Health Center - School of Dental Medicine; 🇺🇸 Farmington, Connecticut, United States

University of Pennsylvania School of Dental Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

University of North Carolina School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States

New York University - College of Dentistry; 🇺🇸 New York, New York, United States