Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: Amoxicillin

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.