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Head and Neck CancerORARAD IINCT05325970

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

An observational study of Head and Neck Cancer and Dental Diseases, run by Wake Forest University Health Sciences at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
202 participants
Where
6 sitesUnited States
Study dates
Feb 2014to 4 Feb 2026
How long will I take part?
7 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120

  • University of North Carolina School of Dentistry

    Chapel Hill, North Carolina, 27514

  • University of Connecticut Health Center - School of Dental Medicine

    Farmington, Connecticut, 06030

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • New York University - College of Dentistry

    New York, New York, 10010

  • University of Pennsylvania School of Dental Medicine

    Philadelphia, Pennsylvania, 19104-6030

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
dental outcomes, cancer, registry
Medical subject headings
Head and Neck Neoplasms, Stomatognathic Diseases, Osteoradionecrosis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05325970
Study groupRoleWhat they receive
Cohorts Interventions Patients receiving head and neck RTNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 years

  2. 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.

    Measured: 7 years

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

    Clinical attachment loss (CAL) measured in mm

    Measured: 7 years

  4. Pocket depth (Periodontal Measure 3)

    Pocket depth measured in mm

    Measured: 7 years

  5. 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.

    Measured: 7 years

  6. 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.

    Measured: 7 years

  7. 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.

    Measured: 7 years

Secondary outcomes (7)

  1. Trismus measurements in mm

    Change in mouth opening are documented in mm

    Measured: 7 years

  2. 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.

    Measured: 7 years

  3. 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.

    Measured: 7 years

  4. 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).

    Measured: 7 years

  5. 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.

    Measured: 7 years

  6. Mortality

    Measured: 7 years

  7. Cancer recurrence

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2022
  2. Study startFeb 2014
  3. Primary completion4 Feb 2026
  4. Study completion4 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
202 participants (actual)
Target duration
7 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05325970
Sponsor's protocol ID
IRB00091445
Other IDs
U01DE022939, Pro00060322
Acronym
ORARAD II
Status last verified
Jun 2026
First submitted
25 Mar 2022
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: PI will share deidentified data , no other documents, upon reasonable request

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer and Dental Diseases, run by Wake Forest University Health Sciences at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental Caries (time frame: 7 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05325970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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