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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01663246
First received: July 24, 2012
Last updated: December 10, 2013
Last verified: December 2013

July 24, 2012
December 10, 2013
April 2006
October 2007   (final data collection date for primary outcome measure)
  • prevalence of dental caries in patients after PS-IMRT [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01663246 on ClinicalTrials.gov Archive Site
prevalence of periodontal disease after PS-IMRT [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
number of caries in individual subjects will depend on number of teeth and/or surfaces at risk, we will need to report "prevalence" after adjusting for the total surfaces at risk for each patient. In addition, because data in the cross-sectional cohort will be obtained from patients at different follow-up times since RT, the relationship between prevalence and time since RT will need to be explored to take into account the time effect.
Same as current
Not Provided
Not Provided
 
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer

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.

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)

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Procedure: Saliva Sample
Small plastic cups will be placed on the inside of subject cheeks, and held in place with gentle suction. These cups are attached to tubes which will allow the collection of saliva into a test tube. Saliva will also be collected from the glands underneath the tongue using a small gentle suction device, similar to the one used by a dentist. Saliva production will be stimulated by dabbing a mild citric acid solution that tastes like lemon onto the tongue using a Q-Tip. After this test, subjects will also be asked to chew wax to simulate saliva, and the saliva that accumulates in their mouth will be collected by spitting into a test tube.
  • Active Comparator: Healthy Adults
    Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.
    Intervention: Procedure: Saliva Sample
  • Active Comparator: Radiation for Head and Neck Cancer
    History of radiation therapy for head and neck cancer.
    Intervention: Procedure: Saliva Sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2008
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01663246
2005.097, HUM00000970
Yes
University of Michigan Cancer Center
University of Michigan Cancer Center
Not Provided
Principal Investigator: Avraham Eisbruch, MD University of Michigan Cancer Center
University of Michigan Cancer Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP