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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer; Osteoradionecrosis; Dental Diseases

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 Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center - School of Dental Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Brigham and Women's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
  • New York
    • New York, New York, United States, 10010
      • New York University - College of Dentistry
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina School of Dentistry
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-6030
      • University of Pennsylvania School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will be offered to all living ORARAD participants approximately 7 years post-RT. Persons of all races and ethnicities and both females and males will thus be eligible for this study. Because participants will be drawn solely from the participants in the original ORARAD, the racial/ethnic composition of the study population at each center will be determined by the composition of those enrolled in the original ORARAD, which has been documented elsewhere. Since there is no evidence to suggest that dental outcomes in head and neck cancer patients are affected by gender, this expected unequal gender distribution of study participants will not affect the scientific validity of the study. Individuals who meet the eligibility criteria will be invited to participate in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohorts Interventions Patients receiving head and neck RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Caries	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.	7 years
Bleeding on probing is documented (yes/no) (Periodontal Measure 1)	Bleeding on probing is documented (yes/no) and a percentage of "yes" responses will be calculated.	7 years
Clinical attachment loss (CAL) (Periodontal Measure 2)	Clinical attachment loss (CAL) measured in mm	7 years
Pocket depth (Periodontal Measure 3)	Pocket depth measured in mm	7 years
Tooth Loss	"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.	7 years
Exposed intraoral bone	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.	7 years
Salivary flow	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.	7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trismus measurements in mm	Change in mouth opening are documented in mm	7 years
7-year use of fluoride	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.	7 years
Compliance with brushing/flossing	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.	7 years
Changes in RT-specific quality of life measures	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).	7 years
Change in pain scores	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.	7 years
Mortality		7 years
Cancer recurrence		7 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: University of Pennsylvania; NYU Langone Health; Brigham and Women's Hospital; National Institute of Dental and Craniofacial Research (NIDCR); University of Minnesota; UConn Health; University of North Carolina
• Investigators: Principal Investigator: Michael T. Brennan, DDS, MHS, Wake Forest University Health Sciences; Principal Investigator: Rajesh V. Lalla, DDS, PhD, UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cancer; registry; dental outcomes
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms by Site; Radiation Injuries; Neoplasms; Head and Neck Neoplasms; Osteoradionecrosis; Stomatognathic Diseases
• Other Study ID Numbers: IRB00091445; Pro00060322 (Other Identifier: Atrium Health); U01DE022939 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: PI will share deidentified data , no other documents, upon reasonable request
• IPD Sharing Time Frame: immediately after publication, no expiration
• IPD Sharing Access Criteria: send request to either Dr. Brennan (mike.brennan@atriumhealth.org) or Dr. Rajesh Lalla (lalla@uconn.edu).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No