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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 : Active, not recruiting
First Posted : February 7, 2014
Last Update Posted : July 23, 2018
Sponsor:
Collaborators:
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
University of North Carolina
Information provided by (Responsible Party):
Michael T. Brennan, Carolinas Healthcare System

February 5, 2014
February 7, 2014
July 23, 2018
February 2014
November 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02057510 on ClinicalTrials.gov Archive Site
  • 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
  • Extraction complications [ Time Frame: Within 14 days following procedure ]
    Incidence of post-extraction complications
  • Decayed, Missing or Filled Surfaces (DMFS) Index [ Time Frame: Baseline, 24 months ]
    Two year change in DMFS - Decayed, Missing or Filled Surfaces Index
  • Periodontal Measures [ Time Frame: Baseline, 24 months ]
    Two year change in periodontal measures
  • Stimulated Salivary Flow Rate [ Time Frame: Baseline, 18 months ]
    18 month changes in stimulated whole salivary flow rates
  • Trismus measure [ Time Frame: Baseline, 24 months ]
    Two year change in mouth opening in mm
  • Topical fluoride use for caries prevention [ Time Frame: Baseline, 24 months ]
    Two year use of fluoride to prevent new caries
  • Chronic Oral Mucositis Incidence [ Time Frame: Baseline, 24 months ]
    Two year chronic oral mucositis incidence
  • Quality of Life after Radiation Therapy [ Time Frame: Baseline, 24 months ]
    Two year change in radiation therapy-specific quality of life measures
  • 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
Same as current
Not Provided
Not Provided
 
Observational Study of Dental Outcomes in Head and Neck Cancer Patients
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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
24 Months
Not Provided
Non-Probability Sample
Head and Neck Radiation Oncology patients
  • Head and Neck Cancer
  • Dental Disease
  • Xerostomia
  • Osteoradionecrosis
Not Provided
Patients receiving head and neck RT
No intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
575
756
November 2020
November 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02057510
12-040-E
1U01DE022939-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Michael T. Brennan, Carolinas Healthcare System
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
  • University of North Carolina
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
Carolinas Healthcare System
July 2018