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Dental Study in Cancer Patients With Central Venous Catheters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rajesh Lalla, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00798330
First received: November 25, 2008
Last updated: November 19, 2013
Last verified: November 2013
  Purpose
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.

Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

Further study details as provided by Rajesh Lalla, University of Connecticut Health Center:

Primary Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer outpatients with central venous catheters (Medport or PICC lines)
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798330

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
Rajesh Lalla
Investigators
Principal Investigator: Rajesh V Lalla, DDS, Ph.D UConn Health
  More Information

Responsible Party: Rajesh Lalla, Associate Professor, School of Dental Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00798330     History of Changes
Other Study ID Numbers: 09-059-2
786-001
Study First Received: November 25, 2008
Last Updated: November 19, 2013

Keywords provided by Rajesh Lalla, University of Connecticut Health Center:
Cancer
Blood stream infections
Bacteremia
Dental procedure
Central venous catheters
Mediport
PICC line

ClinicalTrials.gov processed this record on September 21, 2017