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Clinical Trials/NCT01663246
NCT01663246
Completed
Not Applicable

Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer

University of Michigan Rogel Cancer Center1 site in 1 country50 target enrollmentApril 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
University of Michigan Rogel Cancer Center
Enrollment
50
Locations
1
Primary Endpoint
prevalence of dental caries in patients after PS-IMRT
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The investigators are conducting research about oral health and saliva to find out more about the impact of radiation therapy on the oral health of patients.

In order to better understand the role of saliva in maintaining oral health in these patients, the investigators will be collecting, storing, and analyzing the quality of saliva, including the protein content, collected from patients following radiation therapy as well as saliva collected from normal healthy adults.

Detailed Description

Radiation-induced xerostomia is the most common long term complication of head and neck radiation, is usually permanent and is the most frequent reason for reduced quality of life in these patients. The loss of antimicrobial, buffering, cleansing and remineralizing effects of saliva markedly increases the risk for dental caries. Extractions of diseased teeth located in irradiated bone and dental infection involving the bone can trigger osteoradionecrosis (ORN), another serious complication of high dose radiation of the jaws. Therefore, current dental treatment guidelines recommend the extraction of diseased teeth and any teeth that might require extraction in the future, before radiation therapy. (NCI, 1990; Rankin et al, 2003; NIDCR, 2005) As a result, patients with head and neck cancer often have many or all teeth extracted, especially those patients who are judged unlikely to comply with lifelong, daily topical fluoride, oral hygiene practices and frequent professional dental care. (Bruins et al, 1999)

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
December 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Avraham Eisbruch

Newman Family Professor of Radiation Oncology and Professor of Radiation

University of Michigan Rogel Cancer Center

Eligibility Criteria

Inclusion Criteria

  • All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and neck cancer at University of Michigan.
  • At least 6 months has elapsed since the completion of RT, at the time of assessment for this study.
  • All subjects must sign a University of Michigan Health System- IRB approved informed consent.
  • Documented Karnofsky performance status \> 60
  • These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease

Exclusion Criteria

  • History of surgical removal of major salivary gland(s).
  • Patients edentulous prior to radiation therapy.
  • Pregnancy or lactation
  • Patients residing in prison.
  • Age\< 18 years.

Outcomes

Primary Outcomes

prevalence of dental caries in patients after PS-IMRT

Time Frame: 24 Months

Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products

prevalence of tooth loss in patients after PS-IMRT

Time Frame: 24 months

Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products

Secondary Outcomes

  • prevalence of periodontal disease after PS-IMRT(24 Months)

Study Sites (1)

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