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Completed

NCT Number: NCT05325970

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

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.

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Key information

Conditions

Head and Neck Cancer Dental Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Osteoradionecrosis Radiation Injuries Stomatognathic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Dental Caries

    Time frame: 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.

  2. Bleeding on probing is documented (yes/no) (Periodontal Measure 1)

    Time frame: 7 years

    Bleeding on probing is documented (yes/no) and a percentage of "yes" responses will be calculated.

  3. Clinical attachment loss (CAL) (Periodontal Measure 2)

    Time frame: 7 years

    Clinical attachment loss (CAL) measured in mm

  4. Pocket depth (Periodontal Measure 3)

    Time frame: 7 years

    Pocket depth measured in mm

  5. Tooth Loss

    Time frame: 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.

  6. Exposed intraoral bone

    Time frame: 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.

  7. Salivary flow

    Time frame: 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 outcomes

  1. Trismus measurements in mm

    Time frame: 7 years

    Change in mouth opening are documented in mm

  2. 7-year use of fluoride

    Time frame: 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.

  3. Compliance with brushing/flossing

    Time frame: 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.

  4. Changes in RT-specific quality of life measures

    Time frame: 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).

  5. Change in pain scores

    Time frame: 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.

  6. Mortality

    Time frame: 7 years

  7. Cancer recurrence

    Time frame: 7 years

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Brigham and Women's Hospital
  • NYU Langone Health
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • UConn Health
  • University of Minnesota
  • University of North Carolina
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: ORARAD II

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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