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

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Procedure: Saliva Sample

• Registration Number: NCT01663246
• Lead Sponsor: University of Michigan Rogel Cancer Center

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)

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-10
• Study Completion: 2008-12
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Adults	Saliva Sample	Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.
Radiation for Head and Neck Cancer	Saliva Sample	History of radiation therapy for head and neck cancer.

Primary Outcome Measures

Name	Time	Method
prevalence of dental caries in patients after PS-IMRT	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	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 Outcome Measures

Name	Time	Method
prevalence of periodontal disease after PS-IMRT	24 Months	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.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States