Overview

A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Santiago de Compostela
Collaborator:
Hospital Clinico Universitario de Santiago
Treatments:
Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Chlorhexidine
Chlorhexidine gluconate
Clavulanic Acid
Clavulanic Acids
Polystyrene sulfonic acid
Criteria
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