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Bacteremia | A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

Bacteremia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacteremia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Amoxicillin-Potassium ClavulanateAdminister Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction

Drug:AmoxicillinAdminister Amoxicillin following endotracheal intubation prior to single tooth-extraction

Drug:ChlorhexidineAdminister Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ControlReceiving no prophylaxis

AmoxicillinReceiving 2 g Amoxicillin intravenously before any dental manipulation and following endotracheal intubation

Amoxicillin-Potassium ClavulanateReceiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. before any dental manipulation and following endotracheal intubation

Chlorhexidine (CHX)Receiving a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation

Amoxicillin-Potassium Clavulanate-CHXReceiving 1000/200mg Amoxicillin-Potassium Clavulanate i.v. and a single 0.2% Chlorhexidine (CHX) mouthwash for 30 seconds before any dental manipulation and following endotracheal intubation

Study Status

Completed

Start Date: January 2014

Completed Date: May 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Number of participants receiving a prophylactic dosage with amoxicillin-clavulanate i.v. with bacteremia following dental extractions

Secondary Outcome: Number of participants receiving a prophylactic dosage with amoxicillin i.v. (following the American Heart Association┬┤s guidelines) with bacteremia after dental extractions

Study sponsors, principal investigator, and references

Principal Investigator: Pedro Diz, MD,DDS,PhD

Lead Sponsor: University of Santiago de Compostela

Collaborator: Hospital Clinico Universitario de Santiago

More information:https://clinicaltrials.gov/show/NCT02115776

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.

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