CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 208 enrolled
Drug / intervention
0.2% Chlorhexidine +5 moredrug
Likely dose
0.2% Chlorhexidine 10 mlfrom record
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Search/NCT02150031
NCT02150031Phase 4Completed

Bacteraemia Secondary to Tooth Extraction: a Randomized Clinical Trial on Efficacy of Three Different Chlorhexidine Prophylaxis Protocols

University of Santiago de Compostela·interventional·Posted May 29, 2014·Updated May 29, 2014

In Brief

A Phase 4 clinical trial evaluating 0.2% Chlorhexidine, 1% Chlorhexidine, and 3 other interventions for Bacteremia and Tooth Extraction Status Nos. Completed, enrolled 208 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 29, 2014
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.1 years ago

Interventions

0.2% Chlorhexidinedrug

mouthwash with 10 ml for 1 minute

1% Chlorhexidinedrug

subgingival irrigation

1% Chlorhexidinedrug

supragingival irrigation

Blood extractionprocedure

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

Lidocaine plus adrenalinedrug

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

Tooth extractionprocedure

dental extraction