A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures

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.

Conditions

• Bacteremia

Interventions

DRUG

Amoxicillin-Potassium Clavulanate

Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction

DRUG

Amoxicillin

Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction

DRUG

Chlorhexidine

Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago

  collaborator OTHER

• University of Santiago de Compostela

  lead OTHER

Principal Investigators

• Pedro Diz, MD,DDS,PhD · Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago

• Jacobo Limeres, DDS,PhD · Universidad de Santiago (Grupo OMEQUI-2117)

• Javier Alvarez, MD,DDS · Universidad de Santiago (Grupo OMEQUI-2117)

• Javier F Feijoo, MD,DDS,PhD · Universidad de Santiago (Grupo OMEQUI-2117); Hospital Clínico Universitario de Santiago

• Marcio Diniz, DDS,PhD · Universidad de Santiago (Grupo OMEQUI-2117)

• Mercedes Outumuro, DDS,PhD · Universidad de Santiago (Grupo OMEQUI-2117)

• Juan Medina, MD,Anest,PhD · Hospital Clínico Universitario de Santiago

• Miguel Castro, MD,DDS, PhD · Universidad de Santiago (Grupo OMEQUI-2117)

• Maximiliano Alvarez, MD,Micro,PhD · Hospital Clínico Universitario de Vigo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2015-04-30

Completion

2015-05-31

Countries

• Spain

Study Locations