Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00454285
First received: March 29, 2007
Last updated: December 2, 2009
Last verified: December 2009
  Purpose

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

  1. 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);
  2. 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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Bacteremia From Dental Extractions vs. Oral Hygiene

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

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:
    Drug: Effect of Amoxicillin on bacteremia following a single-tooth extraction
    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
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: NCT00454285

Locations
United States, North Carolina
Carolinas Medical Center Dental Clinic
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
Principal Investigator: Peter B. Lockhart,, DDS Carolinas Medical Center
  More Information

No publications provided by Carolinas Healthcare System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter B. Lockhart, Principal Investigator, Carolinas Medical Center
ClinicalTrials.gov Identifier: NCT00454285     History of Changes
Other Study ID Numbers: 13559, R01DE013559-01, 1 R01 DE13559-01A2
Study First Received: March 29, 2007
Last Updated: December 2, 2009
Health Authority: United States: Federal Government

Keywords provided by Carolinas Healthcare System:
bacteremia,cultures, infective endocarditis, prophylaxis

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014