NCT02150031

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

Completed Phase 4 Last updated 25 May 2014

What this trial tests

Phase 4 trial testing 0.2% Chlorhexidine in Bacteremia in 208 participants. Completed in 1 June 2012.

Timeline

1 December 2010

Primary endpoint
1 May 2012

1 June 2012

Quick facts

Lead sponsor	University of Santiago de Compostela
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	208
Start date	1 December 2010
Primary completion	1 May 2012
Estimated completion	1 June 2012
Sites	2 locations across Portugal, Spain

Drugs / interventions tested

• 0.2% Chlorhexidine — full drug profile →
• 1% Chlorhexidine — full drug profile →
• 1% Chlorhexidine — full drug profile →
• Blood extraction — full drug profile →
• Lidocaine plus adrenaline — full drug profile →
• Tooth extraction

Conditions studied

• Bacteremia — all drugs for Bacteremia →
• Tooth Extraction Status Nos — all drugs for Tooth Extraction Status Nos →

Sponsor

University of Santiago de Compostela

Who can join

18 and older, any sex, with Bacteremia or Tooth Extraction Status Nos. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes in the prevalence of bacteraemia
  Time frame: before and 30 seconds after the antiseptic aplication and 30 seconds and 15 minutes after dental extraction.
  Presence of bacteria and how long it lasts in the blood stream.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-tooth extraction bacteraemia: a randomized clinical trial on the efficacy of chlorhexidine prophylaxis.
   Barbosa M, Prada-López I, Álvarez M, Amaral B, et al · · 2015 · cited 15× · PMID 25955349 · DOI 10.1371/journal.pone.0124249