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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05325970
Other study ID # IRB00091445
Secondary ID U01DE022939Pro00
Status Active, not recruiting
Phase
First received
Last updated
Start date February 2014
Est. completion date June 2025

Study information

Verified date February 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 350
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States University of North Carolina School of Dentistry Chapel Hill North Carolina
United States University of Connecticut Health Center - School of Dental Medicine Farmington Connecticut
United States University of Minnesota Minneapolis Minnesota
United States New York University - College of Dentistry New York New York
United States University of Pennsylvania School of Dental Medicine Philadelphia Pennsylvania

Sponsors (8)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Brigham and Women's Hospital, National Institute of Dental and Craniofacial Research (NIDCR), NYU Langone Health, UConn Health, University of Minnesota, University of North Carolina, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Clinical attachment loss (CAL) (Periodontal Measure 2) Clinical attachment loss (CAL) measured in mm 7 years
Primary Pocket depth (Periodontal Measure 3) Pocket depth measured in mm 7 years
Primary 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
Primary 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
Primary 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 Trismus measurements in mm Change in mouth opening are documented in mm 7 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Mortality 7 years
Secondary Cancer recurrence 7 years
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