A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

Bacteremia Clinical Trial

Official title:

A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115776
• Other study ID #: PGIDIT05PXIB92501PR
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: May 26, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a chlorhexidine mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.

The study hypothesis is that an antimicrobial regimen with amoxicillin-clavulanate will show higher effectiveness in reducing the prevalence and duration of bacteremia following dental extractions, than that achieved with the classical amoxicillin regimen.

Description:

PURPOSE: Despite the controversy about the risk of developing bacterial endocarditis of oral origin, numerous Expert Committees in different countries continue to publish prophylactic regimens. To date, the literature is unclear about the role of antimicrobial prophylaxis in the prevention of bacteremia following dental procedures. The aim of this study is to evaluate the efficacy of prophylactic dosage with amoxicillin (AMX), amoxicillin-clavulanate (AMX-CLV), and a combination of amoxicillin-clavulanate and a CHX mouthwash (AMX-CLV-CHX) in the prevention of bacteremia following dental extractions.

SELECTION OF THE STUDY GROUP AND STUDY DESIGN: The study group will comprise patients who, for behavioral reasons (autism, learning disabilities, phobias, etc.), will undergo dental extractions under general anesthesia in the Santiago de Compostela University Hospital (Santiago de Compostela, Spain). The following exclusion criteria will be applied: age under 18 years; body weight under 40 kg; receipt of antibiotics in the previous 3 months; routine use of oral antiseptics; a history of allergy or intolerance to AMX, CHX or AMX-CLV; any type of congenital or acquired immunodeficiency; or any known risk factor for bacterial endocarditis. By applying these criteria, 200 patients will be selected and will be randomly distributed into 5 study groups: control group (receiving no prophylaxis), AMX group (receiving 2 g AMX i.v.), AMX-CLV group (receiving 1000/200mg AMX-CLV i.v.), CHX group (receiving a single 0.2% CHX mouthwash for 30 seconds), and AMX-CLV-CHX group (receiving 1000/200mg AMX-CLV i.v. and a single 0.2% CHX mouthwash for 30 seconds).

COLLECTION OF SAMPLES FOR BLOOD CULTURE: To determine the prevalence of bacteremia, a peripheral venous blood sample (10 ml) will be drawn from each patient at the baseline (before any dental manipulation but after nasotracheal intubation) and 30 s, 15 min, and 1 h after the final dental extraction. Samples will be inoculated in BACTEC plus (Becton Dickinson and Company, Sparks, MD) aerobic and anaerobic blood culture bottles, and will be processed in the Bactec 9240 (Becton Dickinson).

MICROBIOLOGICAL ANALYSIS OF BLOOD CULTURES: A Gram stain will be performed on each positive blood culture. The positive blood cultures in the aerobic media will be subcultured on blood agar and chocolate agar in an atmosphere of 5 to 10% carbon monoxide and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive blood cultures in the anaerobic media, with subculture on Schaedler agar and incubation in an anaerobic atmosphere. The bacteria isolated will be identified by using the battery of biochemical tests provided with the Vitek system for Gram-positive bacteria, Neisseria spp., Haemophilus spp., and obligate anaerobic bacteria. The viridans group streptococci will be classified into five groups, the Streptococcus mitis, S. anginosus, S. salivarius, S. mutans, and S. bovis groups, by applying the Ruoff criteria. Facklam's criteria will be used to identify unusual Streptococcus spp. and other gram-positive cocci in chains.

The subculture and further identification of the isolated bacteria will be performed by conventional microbiological techniques. The collection, handling, and transport of the blood samples for blood culture will be performed according to the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects must have at least 10 teeth

• Subjects must have the need for a dental extraction under general anesthesia (for behavioral reasons)

• Subjects will be recruited regardless of the extent and severity of their dental and/or periodontal disease

Exclusion Criteria:

• Age under 18 years

• Body weight under 40 kg

• Receipt of antibiotics in the previous 3 months

• Routine use of oral antiseptics

• A history of allergy or intolerance to amoxicillin

• A history of allergy or intolerance to chlorhexidine

• A history of allergy or intolerance to amoxicillin-clavulanate

• Any type of congenital or acquired immunodeficiency

• Any known risk factor for bacterial endocarditis

• Any known risk factor for prolonged bleeding

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• Amoxicillin-Potassium Clavulanate
Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
• Amoxicillin
Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction
• Chlorhexidine
Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario de Santiago	Santiago de Compostela	A Coruña
Spain	Santiago de Compostela University Hospital	Santiago de Compostela	Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Diz Dios P, Tomás Carmona I, Limeres Posse J, Medina Henríquez J, Fernández Feijoo J, Alvarez Fernández M. Comparative efficacies of amoxicillin, clindamycin, and moxifloxacin in prevention of bacteremia following dental extractions. Antimicrob Agents Chemother. 2006 Sep;50(9):2996-3002. — View Citation

Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13. Review. — View Citation

Piñeiro A, Tomás I, Blanco J, Alvarez M, Seoane J, Diz P. Bacteraemia following dental implants' placement. Clin Oral Implants Res. 2010 Sep;21(9):913-8. doi: 10.1111/j.1600-0501.2010.01928.x. — View Citation

Tomás I, Alvarez M, Limeres J, Potel C, Medina J, Diz P. Prevalence, duration and aetiology of bacteraemia following dental extractions. Oral Dis. 2007 Jan;13(1):56-62. — View Citation

Tomás I, Diz P, Tobías A, Scully C, Donos N. Periodontal health status and bacteraemia from daily oral activities: systematic review/meta-analysis. J Clin Periodontol. 2012 Mar;39(3):213-28. doi: 10.1111/j.1600-051X.2011.01784.x. Epub 2011 Sep 15. Review. — View Citation

Tomás I, Pereira F, Llucián R, Poveda R, Diz P, Bagán JV. Prevalence of bacteraemia following third molar surgery. Oral Dis. 2008 Jan;14(1):89-94. doi: 10.1111/j.1601-0825.2006.01359.x. — View Citation

Valdés C, Tomás I, Alvarez M, Limeres J, Medina J, Diz P. The incidence of bacteraemia associated with tracheal intubation. Anaesthesia. 2008 Jun;63(6):588-92. doi: 10.1111/j.1365-2044.2008.05449.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of control participants with bacteremia following dental extractions under general anesthesia	Percentage of control participants with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction	Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction	No
Primary	Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia following dental extractions	Percentage of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction	Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction	No
Secondary	Number of participants receiving a prophylactic dosage with amoxicillin i.v. (following the American Heart Association´s guidelines) with bacteremia after dental extractions	Percentage of participants receiving a prophylactic dosage with amoxicillin i.v. with bacteremia confirmed by microbiological analysis at 30 seconds, 15 minutes and 1 hour after the final dental extraction	Changes from baseline in prevalence of bacteremia at 30 seconds, 15 minutes and 1 hour after the final dental extraction	No