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| ID | Type | Description | Link |
|---|---|---|---|
| R01DE013559-01 | U.S. NIH Grant/Contract | View source | |
| 1R01DE013559-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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The major purposes of this prospective, randomized, clinical study are to:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effect of Amoxicillin on bacteremia following a single-tooth extraction | Drug | Administer Amoxicillin 1 hour prior to single-tooth extraction. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of bacteremia in three groups | Blood Draws at 0, 2.5, and 5 minutes; and at 20. 40, and 60 minutes. |
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Inclusion criteria:
Exclusion criteria:
.Subjects with active viral infectious disease (e.g., hepatitis).
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| Name | Affiliation | Role |
|---|---|---|
| Peter B. Lockhart,, DDS | Carolinas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center Dental Clinic | Charlotte | North Carolina | 28203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19797553 | Derived | Lockhart PB, Brennan MT, Thornhill M, Michalowicz BS, Noll J, Bahrani-Mougeot FK, Sasser HC. Poor oral hygiene as a risk factor for infective endocarditis-related bacteremia. J Am Dent Assoc. 2009 Oct;140(10):1238-44. doi: 10.14219/jada.archive.2009.0046. |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |