Dental Study in Cancer Patients With Central Venous Catheters

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.

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Key information

Conditions

Cancer Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients willing and able to provide written informed consent for the study.
Patients diagnosed with cancer and being treated at the University of Connecticut Health Center.
Patients scheduled to receive or who have received a central venous catheter
Patients who have at least one tooth.

Exclusion criteria

Patients under the age of 18
Patients who have received any antibacterial in the time period starting 48 hours before the dental cleaning. This includes systemic antibacterials and topical antibacterials in the oral cavity or at/through the CVC site. (Topical antibacterials at other sites are allowed; antifungal and antiviral agents in any form are allowed).
Patients who plan to use antibacterials within the 24 hours after the procedure (until the final blood sample is obtained).
Patients with a documented blood stream infection within 1 month prior to proposed dental cleaning.
Patients with a clinically significant coagulation disorder or patients on warfarin.
Patients who require antibiotic prophylaxis as per American College of Cardiology/American Heart Association (ACC/AHA) 2007 guidelines, namely;
patients who have had a cardiac transplantation,
incomplete cardiac valve repair,
complete cardiac valve repair in last 6 months,
prior history of infective endocarditis ,
patients with a prosthetic cardiac valve.
Patients with any other condition which might preclude participation in the opinion of the patient's physician(s) or the study PI's.

Treatment and study plan

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rajesh Lalla

Other

Registry information

Official study title

Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Nov 26, 2008
Registry last updated: Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed