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

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ClinicalTrials.gov Identifier: NCT02057510
Recruitment Status : Recruiting
First Posted : February 7, 2014
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Head and Neck Cancer Dental Disease Xerostomia Osteoradionecrosis

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. Seven hundred and fifty-six 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 Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 756 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients
Study Start Date : February 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Patients receiving head and neck RT
No intervention

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. Extraction complications [ Time Frame: Within 14 days following procedure ]
    Incidence of post-extraction complications

  3. Decayed, Missing or Filled Surfaces (DMFS) Index [ Time Frame: Baseline, 24 months ]
    Two year change in DMFS - Decayed, Missing or Filled Surfaces Index

  4. Periodontal Measures [ Time Frame: Baseline, 24 months ]
    Two year change in periodontal measures

  5. Stimulated Salivary Flow Rate [ Time Frame: Baseline, 18 months ]
    18 month changes in stimulated whole salivary flow rates

  6. Trismus measure [ Time Frame: Baseline, 24 months ]
    Two year change in mouth opening in mm

  7. Topical fluoride use for caries prevention [ Time Frame: Baseline, 24 months ]
    Two year use of fluoride to prevent new caries

  8. Chronic Oral Mucositis Incidence [ Time Frame: Baseline, 24 months ]
    Two year chronic oral mucositis incidence

  9. Quality of Life after Radiation Therapy [ Time Frame: Baseline, 24 months ]
    Two year change in radiation therapy-specific quality of life measures

  10. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Head and Neck Radiation Oncology patients

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;


  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057510

United States, Connecticut
University of Connecticut Health Center - School of Dental Medicine Recruiting
Farmington, Connecticut, United States, 06030
Contact: Jennifer Plascencia, RDH    860-679-3918    plascencia@uchc.edu   
Contact: Cynthia Rybczyk, RDH    860-679-3918    rybczyk@uchc.edu   
Principal Investigator: Rajesh Lalla, DDS, PhD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Sujata Syamal    617-732-6813    ssyamal@mgh.harvard.edu   
Contact: Lisa Johnson, RDH       lbennettjohnson@partners.org   
Principal Investigator: Nathaniel Treister, DMD         
United States, New York
New York University - College of Dentistry Recruiting
New York, New York, United States, 10010
Contact: Makeda Culley    212-998-9202    makeda.culley@nyu.edu   
Principal Investigator: Brian Schmidt, DDS, MD, PhD         
United States, North Carolina
University of North Carolina - School of Dentistry Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jo Ann Blake, RDH    919-537-3361    Jo-Ann_Blake@unc.edu   
Principal Investigator: Lauren Patton, DDS         
Carolinas Medical Center - Dental Clinic Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Maggie Tanner, RN, RDH    704-355-0174    maggie.tanner@carolinashealthcare.org   
Principal Investigator: Michael Brennan, DDS, MHS         
United States, Pennsylvania
University of Pennsylvania - School of Dental Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dan Vernau    215-349-5409    vernaud@mail.med.upenn.edu   
Principal Investigator: Thomas Sollecito, DDS         
Sponsors and Collaborators
Carolinas Healthcare System
National Institute of Dental and Craniofacial Research (NIDCR)
University of Minnesota - Clinical and Translational Science Institute
UConn Health
University of Pennsylvania
Brigham and Women's Hospital
New York University School of Medicine
Study Chair: Michael T Brennan, DDS, MHS Carolinas Healthcare System
Study Chair: Rajesh Lalla, DDS, PhD University of Connecticut Health Center - School of Dental Medicine
More Information

Responsible Party: Michael T. Brennan, Michael Brennan, DDS, MHS, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT02057510     History of Changes
Other Study ID Numbers: 12-040-E
1U01DE022939-01 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Michael T. Brennan, Carolinas Healthcare System:
Head and Neck Cancer
Radiation Therapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatognathic Diseases
Neoplasms by Site
Salivary Gland Diseases
Mouth Diseases
Radiation Injuries
Wounds and Injuries