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Completed

NCT Number: NCT00454285

Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Carolinas Medical Center Dental Clinic

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Effect of Amoxicillin on bacteremia following a single-tooth extraction

Drug

Administer Amoxicillin 1 hour prior to single-tooth extraction.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Bacteremia From Dental Extractions vs. Oral Hygiene

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Mar 30, 2007
Registry last updated
Apr 25, 2022

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.

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