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 : January 29, 2020
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Condition or disease |
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Head and Neck Cancer Dental Disease Xerostomia Osteoradionecrosis |
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 [Patient Registry] |
Actual Enrollment : | 575 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 : | November 2020 |
Estimated Study Completion Date : | November 2020 |

Group/Cohort |
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Patients receiving head and neck RT
No intervention
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- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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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:
- base of tongue
- buccal/labial mucosa
- epiglottis
- floor of mouth
- gingiva/alveolar ridge
- hard palate
- hypopharynx
- larynx
- lip
- mandible
- maxilla
- maxillary sinus
- nasal cavity
- nasopharynx
- neck
- oral cavity
- oral tongue
- oropharynx
- paranasal sinus/orbit
- parotid gland
- pharynx
- retromolar trigone
- soft palate
- sublingual gland
- submandibular gland
- 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.

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 | |
Farmington, Connecticut, United States, 06030 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02120 | |
United States, New York | |
New York University - College of Dentistry | |
New York, New York, United States, 10010 | |
United States, North Carolina | |
University of North Carolina - School of Dentistry | |
Chapel Hill, North Carolina, United States, 27599 | |
Carolinas Medical Center - Dental Clinic | |
Charlotte, North Carolina, United States, 28203 | |
United States, Pennsylvania | |
University of Pennsylvania - School of Dental Medicine | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Michael T Brennan, DDS, MHS | Atrium Health | |
Study Chair: | Rajesh Lalla, DDS, PhD | University of Connecticut Health Center - School of Dental Medicine |
Publications of Results:
Responsible Party: | Michael T. Brennan, Michael Brennan, DDS, MHS, Atrium Health |
ClinicalTrials.gov Identifier: | NCT02057510 |
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: | January 29, 2020 |
Last Verified: | January 2020 |
Head and Neck Cancer Radiation Therapy |
Head and Neck Neoplasms Xerostomia Stomatognathic Diseases Osteoradionecrosis Neoplasms by Site |
Neoplasms Salivary Gland Diseases Mouth Diseases Radiation Injuries Wounds and Injuries |