Clinical Trial: Observational Study of Dental Outcomes in Head and Neck Cancer Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

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 Summary:

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.


Sponsor: Carolinas Healthcare System

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Carolinas Healthcare System

Dates:
Date Received: February 5, 2014
Date Started: February 2014
Date Completion: May 2017
Last Updated: May 2, 2016
Last Verified: May 2016