Status:
COMPLETED
Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Bacteremia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 blo...
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 dura...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00454285
Start Date
January 1 2003
End Date
June 1 2006
Last Update
April 25 2022
Active Locations (1)
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1
Carolinas Medical Center Dental Clinic
Charlotte, North Carolina, United States, 28203