Observational Study of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)

August 4, 2023 updated by: Wake Forest University Health Sciences

Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-five participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.

Study Type

Observational

Enrollment (Actual)

575

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
    • New York
      • New York, New York, United States, 10010
        • New York University - College of Dentistry
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - School of Dentistry
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center - Dental Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania - School of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Head and Neck Radiation Oncology patients

Description

Inclusion Criteria:

  • Aged 18 years and older;
  • Willing and able to provide signed and dated consent form;
  • Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;

OR

  • Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:

    1. base of tongue
    2. buccal/labial mucosa
    3. epiglottis
    4. floor of mouth
    5. gingiva/alveolar ridge
    6. hard palate
    7. hypopharynx
    8. larynx
    9. lip
    10. mandible
    11. maxilla
    12. maxillary sinus
    13. nasal cavity
    14. nasopharynx
    15. neck
    16. oral cavity
    17. oral tongue
    18. oropharynx
    19. paranasal sinus/orbit
    20. parotid gland
    21. pharynx
    22. retromolar trigone
    23. soft palate
    24. sublingual gland
    25. submandibular gland
    26. tonsil;
  • At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any;
  • Willing to comply with all study procedures;
  • Willing to participate for the duration of the study.

Exclusion Criteria:

  • Receiving palliative RT;
  • History of prior curative RT to the head and neck region to eradicate a malignancy;
  • Incarcerated at time of screening;
  • Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients receiving head and neck RT
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth loss
Time Frame: Two Years

The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer.

"Tooth loss" will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction:

  • non-restorable because of fracture or extent of caries;
  • amputated crown with root remaining;
  • uncontrolled or persistent periodontal or odontogenic infection.
Two Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of exposed intraoral bone
Time Frame: Two Years
Two year incidence of exposed intraoral bone, suggestive of ORN. This will be defined as exposed maxillary or mandibular bone with an avascular appearance in a quadrant that has received RT
Two Years
Extraction complications
Time Frame: Within 14 days following procedure
Incidence of post-extraction complications
Within 14 days following procedure
Decayed, Missing or Filled Surfaces (DMFS) Index
Time Frame: Baseline, 24 months
Two year change in DMFS - Decayed, Missing or Filled Surfaces Index
Baseline, 24 months
Periodontal Measures
Time Frame: Baseline, 24 months
Two year change in periodontal measures
Baseline, 24 months
Stimulated Salivary Flow Rate
Time Frame: Baseline, 18 months
18 month changes in stimulated whole salivary flow rates
Baseline, 18 months
Trismus measure
Time Frame: Baseline, 24 months
Two year change in mouth opening in mm
Baseline, 24 months
Topical fluoride use for caries prevention
Time Frame: Baseline, 24 months
Two year use of fluoride to prevent new caries
Baseline, 24 months
Chronic Oral Mucositis Incidence
Time Frame: Baseline, 24 months
Two year chronic oral mucositis incidence
Baseline, 24 months
Quality of Life after Radiation Therapy
Time Frame: Baseline, 24 months
Two year change in radiation therapy-specific quality of life measures
Baseline, 24 months
Oral Cancer Pain Scale
Time Frame: Baseline, 24 months
Two year change in pain scores as measured with the University of California at San Francisco (UCSF) oral cancer pain scale
Baseline, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

  • Study Chair: Michael T Brennan, DDS, MHS, Wake Forest University Health Sciences
  • Study Chair: Rajesh Lalla, DDS, PhD, University of Connecticut Health Center - School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 5, 2014

First Posted (Estimated)

February 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-040-E
  • 1U01DE022939-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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