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


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

prevalence of dental caries in patients after PS-IMRT

Outcome Description:

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

Outcome Time Frame:

24 Months

Safety Issue:

No

Principal Investigator

Avraham Eisbruch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005.097

NCT ID:

NCT01663246

Start Date:

April 2006

Completion Date:

June 2016

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752