Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing - Full Text View

Sponsored by:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier:	NCT00454285

Purpose

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.

Condition	Intervention	Phase
Bacteremia	Drug: Effect of Amoxicillin on bacteremia following a single-tooth extraction	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Bacteremia From Dental Extractions vs. Oral Hygiene

Resource links provided by NLM:

MedlinePlus related topics: Dental Health

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate

U.S. FDA Resources

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Enrollment:	290
Study Start Date:	January 2003
Study Completion Date:	June 2006
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Administer Amoxicillin 1 hour prior to 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454285

Locations

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

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:

Peter B. Lockhart,, DDS

Carolinas Medical Center

More Information

No publications provided

Responsible Party:	Carolinas Medical Center ( Peter B. Lockhart, Principal Investigator )
Study ID Numbers:	13559, 1 R01 DE13559-01A2
Study First Received:	March 29, 2007
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00454285 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Dental and Craniofacial Research (NIDCR):

bacteremia,cultures, infective endocarditis, prophylaxis

Study placed in the following topic categories:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Bacterial Endocarditis
Anti-Infective Agents
Amoxicillin
Endocarditis, Infective
Bacteremia

Endocarditis
Inflammation
Anti-Bacterial Agents
Sepsis
Endocarditis, Bacterial
Infective Endocarditis

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Amoxicillin
Sepsis

Pathologic Processes
Therapeutic Uses
Bacteremia
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009