Dental Study in Cancer Patients With Central Venous Catheters

Completed

• Conditions: Cancer

• Registration Number: NCT00798330
• Lead Sponsor: Rajesh Lalla

Brief Summary

Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (CVC),often called a "port" or a "PICC", placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Study Start: 2012-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the incidence of transient bacteremia and established blood-stream infections (BSIs) by oral microorganisms in cancer patients with CVCs after an invasive dental procedure	Two days, 1 month, 6 months	Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after starting the procedure. Records reviewed at one month and six months post procedure for bloodstream or central venous catheter infection.

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States