Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454285
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2007-03-29
Brief Title:
Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Bacteremia From Dental Extractions vs Oral Hygiene
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Associations guidelines for amoxicillin prophylaxis preventive treatment on the INMD of bacteremia resulting from a single tooth extraction
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 Associations guidelines for amoxicillin prophylaxis preventive treatment on the INMD of bacteremia resulting from a 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 ie 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 Associations 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DE013559-01A2 | NIH | None | httpsreporternihgovquickSearch1R01DE013559-01A2 |
| R01DE013559-01 | NIH | None | None |