NCT01663246

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-10-01
• Completion: 2008-12-01
• First posted: 2012-08-13
• Last updated: 2014-08-15

Locations

1 site across 1 country: United States