Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing
Primary Purpose
Bacteremia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Effect of Amoxicillin on bacteremia following a single-tooth extraction
Sponsored by
About this trial
This is an interventional prevention trial for Bacteremia focused on measuring bacteremia,cultures, infective endocarditis, prophylaxis
Eligibility 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.
Sites / Locations
- Carolinas Medical Center Dental Clinic
Outcomes
Primary Outcome Measures
Overall incidence of bacteremia in three groups
Secondary Outcome Measures
Full Information
NCT ID
NCT00454285
First Posted
March 29, 2007
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT00454285
Brief Title
Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing
Official Title
Bacteremia From Dental Extractions vs. Oral Hygiene
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The major purposes of this prospective, randomized, clinical study are to:
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);
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.
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
bacteremia,cultures, infective endocarditis, prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Effect of Amoxicillin on bacteremia following a single-tooth extraction
Intervention Description
Administer Amoxicillin 1 hour prior to single-tooth extraction.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter B. Lockhart,, DDS
Organizational Affiliation
Carolinas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center Dental Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19797553
Citation
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.
Results Reference
derived
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Bacteria Entering the Blood Stream From Tooth Extractions and Tooth Brushing
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