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.
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
350
University of Connecticut Health Center - School of Dental Medicine
Farmington, Connecticut, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
New York University - College of Dentistry
New York, New York, United States
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.
Time frame: 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.
Time frame: 7 years
Clinical attachment loss (CAL) (Periodontal Measure 2)
Clinical attachment loss (CAL) measured in mm
Time frame: 7 years
Pocket depth (Periodontal Measure 3)
Pocket depth measured in mm
Time frame: 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.
Time frame: 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.
Time frame: 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.
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University of North Carolina School of Dentistry
Chapel Hill, North Carolina, United States
University of Pennsylvania School of Dental Medicine
Philadelphia, Pennsylvania, United States
Time frame: 7 years
Trismus measurements in mm
Change in mouth opening are documented in mm
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 7 years
Mortality
Time frame: 7 years
Cancer recurrence
Time frame: 7 years