Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols

NCT02150031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2014-05-29

No results posted yet for this study

Summary

The first time the American Heart Association (AHA) suggested that disinfection of the gingival sulcus be performed as a complement to antibiotic prophylaxis in patients considered to be at risk of Infective endocarditis (IE) was in their protocol for the prevention of IE published in 1977. This practice was included by the AHA and adopted by other expert committees such as the British Society for Antimicrobial Chemotherapy (BSAC) in subsequent prophylactic regimens. In 1992, the BSAC specified the presentation and concentration of chlorhexidine (CHX) that should be used before starting the dental procedure: 1% gel at the gingival margin or 0.2% mouthwash for five minutes. In 1997, the AHA recognised the need to use antiseptic mouthwashes (CHX or povidone iodine) prior to dental manipulations, although they recommended against the use of gingival irrigators and against the continuous use of antiseptics in order to avoid the selection of resistant micro-organisms In 2006, the BSAC recommended a single mouthwash with 0.2% CHX gluconate (10 ml for 1 minute) before performing dental procedures associated with bacteraemia in patients at risk of IE. In contrast, in 2007, the AHA recommended against the use of any antiseptic prophylaxis protocol.

In 2008, the National Institute for Health and Clinical Excellence of the United Kingdom recently performed a systematic review of the antimicrobial prophylaxis protocols for IE and reported that: "Oral chlorhexidine used as an oral rinse does not significantly reduce the level of bacteraemia following dental procedures". This conclusion was reached after analysis of numerous studies on the efficacy of prophylaxis with CHX for the prevention of post-dental manipulation bacteraemia. However, those studies presented significant methodological differences not only in the dental procedures performed, but also in the concentration of CHX applied and the method of application of the antiseptic solution (mouthwash and/or irrigation), making comparison of the results of the different series difficult.

There are few studies that have analysed the efficacy of the mouthwash of 0.2% CHX (the concentration recommended by the BSAC) in the prevention of post-extraction bacteraemia. Only one study analysed the combination of local irrigation and mouthwash with chlorhexidine before dental extraction, but with a really lower concentration of CHX, only 0.02%.

The objective of this study is to investigate the prevalence, duration and aetiology of bacteraemia secondary to a single tooth extraction after prophylaxis with different CHX protocols.

Conditions

  • Bacteremia
  • Tooth Extraction Status Nos

Interventions

DRUG

0.2% Chlorhexidine

mouthwash with 10 ml for 1 minute

DRUG

1% Chlorhexidine

subgingival irrigation

DRUG

1% Chlorhexidine

supragingival irrigation

PROCEDURE

Blood extraction

Blood extraction using an intravenous access at baseline, 30 seconds after antiseptic aplication, 30 seconds and 15 minutes after tooth extraction.

DRUG

Lidocaine plus adrenaline

local anaesthesia using lidocaine plus adrenaline (1:100,000) no more than 2 cartridges.

PROCEDURE

Tooth extraction

dental extraction

Sponsors & Collaborators

  • University of Santiago de Compostela

    lead OTHER

Principal Investigators

  • Inmaculada Tomas · Senior lecturer at University of Santiago de Compostela

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02150031 on ClinicalTrials.gov