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Observational Study of Dental Outcomes in Head and Neck Cancer Patients

Active, not recruiting
Conditions
Osteoradionecrosis
Dental Disease
Head and Neck Cancer
Xerostomia
Registration Number
NCT02057510
Lead Sponsor
Wake Forest University Health Sciences
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.

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
575
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.

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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.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tooth lossTwo 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
NameTimeMethod
Extraction complicationsWithin 14 days following procedure

Incidence of post-extraction complications

Periodontal MeasuresBaseline, 24 months

Two year change in periodontal measures

Quality of Life after Radiation TherapyBaseline, 24 months

Two year change in radiation therapy-specific quality of life measures

Decayed, Missing or Filled Surfaces (DMFS) IndexBaseline, 24 months

Two year change in DMFS - Decayed, Missing or Filled Surfaces Index

Incidence of exposed intraoral boneTwo 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

Oral Cancer Pain ScaleBaseline, 24 months

Two year change in pain scores as measured with the University of California at San Francisco (UCSF) oral cancer pain scale

Stimulated Salivary Flow RateBaseline, 18 months

18 month changes in stimulated whole salivary flow rates

Trismus measureBaseline, 24 months

Two year change in mouth opening in mm

Topical fluoride use for caries preventionBaseline, 24 months

Two year use of fluoride to prevent new caries

Chronic Oral Mucositis IncidenceBaseline, 24 months

Two year chronic oral mucositis incidence

Trial Locations

Locations (6)

University of Connecticut Health Center - School of Dental Medicine

🇺🇸

Farmington, Connecticut, United States

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

New York University - College of Dentistry

🇺🇸

New York, New York, United States

University of North Carolina - School of Dentistry

🇺🇸

Chapel Hill, North Carolina, United States

Carolinas Medical Center - Dental Clinic

🇺🇸

Charlotte, North Carolina, United States

University of Pennsylvania - School of Dental Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

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