Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing

April 19, 2022 updated by: Wake Forest University Health Sciences

Bacteremia From Dental Extractions vs. Oral Hygiene

The major purposes of this prospective, randomized, clinical study are to:

Determine and compare the true incidence, nature, magnitude, and duration (INMD) of bacteremia (bacteria found in the bloodstream) resulting from a highly invasive dental office procedure (tooth extraction) and a minimally invasive and naturally occurring source of bacteremia (tooth brushing);
Measure the effect of the American Heart Association's guidelines for amoxicillin prophylaxis (preventive treatment) on the INMD of bacteremia resulting from a single tooth extraction.

Study Overview

Status

Completed

Conditions

Bacteremia

Intervention / Treatment

Drug: Effect of Amoxicillin on bacteremia following a single-tooth extraction

Detailed Description

The use of antibiotic prophylaxis to prevent distant site infections (DSI) from oral pathogens remains a controversial issue in clinical practice. Little is known about the incidence, nature, and duration (IND) of bacteremia resulting from dental extractions or tooth brushing, either in the presence or absence of prophylactic antibiotic coverage. The purpose of this prospective, randomized, clinical study of 300 subjects is to characterize the bacteremia resulting from a highly invasive (single extraction) dental office procedure and a minimally invasive and naturally occurring source of bacteremia (i.e., tooth brushing). Subjects will be randomized into three equal groups: extraction with amoxicillin, extraction with placebo, and oral hygiene. The major goals are to: 1) improve our understanding of the IND of bacteremias from 10 specific oral pathogens (S. mitis, S. sanguis, S. oralis, S. intermedius, S. mutans, S. salivarius, F. nucleatum, A. Actinomycetemcomitans, E. corrodens and P. gingivalis) that have been reported to cause DSI; 2) measure the effect of the American Heart Association's guidelines for amoxicillin prophylaxis on the IND of bacteremia resulting from a single dental extraction. Blood for aerobic and anaerobic cultures will be drawn at six time points before, during, and following these oral procedures. We will employ a highly sensitive broth-based culturing system (i.e., BACTEC) and improve the specificity of the BACTEC results with the use of PCR sequence analysis. Detailed clinical information on the extent of disease in and around the involved teeth will determine the significance of local disease factors on the IND of the bacteremia from oral pathogens. Data from this study should have implications regarding future guidelines and standards of care concerning antibiotic prophylaxis for individuals currently felt to be at risk for DSI.

Study Type

Interventional

Enrollment (Actual)

290

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center Dental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

Subjects must have at least 10 teeth and the need for a dental extraction.
Subjects will be accepted into the study regardless of the extent of their odontogenic and/or periodontal disease, to include Type I through IV American Association of Periodontists classification.

Exclusion criteria:

Subjects who need surgical extractions that require initial removal of bone overlying the surface of a tooth.
Subjects who have taken systemic antibiotics within the previous 2 weeks.
Subjects who require antibiotic coverage, based on current practice guidelines, prior to invasive dental procedures (e.g., cardiac valve abnormalities).

.Subjects with active viral infectious disease (e.g., hepatitis).

Subjects who are immunocompromised (e.g., organ transplant, HIV).
Subjects classified as American Society of Anesthesiology Class III or higher (i.e., a patient with poorly-controlled systemic disease).
Subjects with facial cellulitis.
Subjects who have had any manipulation of the gingiva within 1 hr prior to the study(e.g., eating, tooth brushing, chewing gum).
Subjects with a history of penicillin allergy.
Subjects deemed by the clinician to have a bacterial infection.
Subjects with a temperature of 100.5 degrees Fahrenheit or above.
Venous access unavailable in non-dominant arm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall incidence of bacteremia in three groups Time Frame: Blood Draws at 0, 2.5, and 5 minutes; and at 20. 40, and 60 minutes.	Blood Draws at 0, 2.5, and 5 minutes; and at 20. 40, and 60 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator: Peter B. Lockhart,, DDS, Carolinas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lockhart PB, Brennan MT, Thornhill M, Michalowicz BS, Noll J, Bahrani-Mougeot FK, Sasser HC. Poor oral hygiene as a risk factor for infective endocarditis-related bacteremia. J Am Dent Assoc. 2009 Oct;140(10):1238-44. doi: 10.14219/jada.archive.2009.0046.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria