Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols

NCT02150031 | Completed Phase 4

• 1 other identifier: 2008/202 CHX bacteraemia
• Study Type: interventional
• Target: 208
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

prevention and control; chlorhexidine; therapeutic irrigation; mouthwashes; culture

Outcome Measures

Primary Outcomes (1)

• Changes in the prevalence of bacteraemia

  Presence of bacteria and how long it lasts in the blood stream.

  before and 30 seconds after the antiseptic aplication and 30 seconds and 15 minutes after dental extraction.

Study Arms (4)

Control

OTHER

* Blood extraction using the intravenous access 18-22 gauge "angiocath" catheter (Becton Dickinson, Sparks, MD, USA) (at baseline, 30 seconds and 15 minutes after tooth extraction). * No prophylactic Chlorhexidine regimen. * Local anesthesia with lidocaine plus adrenaline (1:100,000). * Tooth extraction.

Procedure: Blood extraction; Drug: Lidocaine plus adrenaline; Procedure: Tooth extraction

CHX-Mouthwash

ACTIVE COMPARATOR

* Blood extraction using the intravenous access 18-22 gauge "angiocath" catheter (Becton Dickinson, Sparks, MD, USA)(at baseline, 30 seconds and 15 minutes after tooth extraction). * Mouthwash with 0.2% Chlorhexidine (10 ml for 1 minute) (Oraldine Perio®, Johnson and Johnson, Barcelona, Spain). * Local anesthesia with lidocaine plus adrenaline (1:100,000). * Tooth extraction.

Drug: 0.2% Chlorhexidine; Procedure: Blood extraction; Drug: Lidocaine plus adrenaline; Procedure: Tooth extraction

CHX-MW/SUB_IR

ACTIVE COMPARATOR

* Blood extraction using the intravenous access 18-22 gauge "angiocath" catheter (Becton Dickinson, Sparks, MD, USA) (at baseline, 30 seconds and 15 minutes after tooth extraction). * Mouthwash with 0.2% Chlorhexidine (10 ml for 1 minute) (Oraldine Perio®) and subgingival irrigation with 1% Chlorhexidine on the tooth to be extracted; the irrigation will be done with the Heraeus Citojet Intraligamental Syringe (Kulzer Heraeus S.A., Madrid, Spain) at six points on each tooth (3 points on the vestibular surface and 3 on the palatine surface). * Local anesthesia with lidocaine plus adrenaline (1:100,000). * Tooth extraction.

Drug: 0.2% Chlorhexidine; Drug: 1% Chlorhexidine; Procedure: Blood extraction; Drug: Lidocaine plus adrenaline; Procedure: Tooth extraction

CHX-MW/SUPRA_IR

ACTIVE COMPARATOR

* Blood extraction using the intravenous access 18-22 gauge "angiocath" catheter (Becton Dickinson, Sparks, MD, USA)(at baseline, 30 seconds and 15 minutes after tooth extraction). * Mouthwash with 0.2% Chlorhexidine (10 ml for 1 minute) (Oraldine Perio®) and then supragingival irrigation with 1% Chlorhexidine on the tooth to be extracted; the irrigation will be done continuously around the tooth to be extracted by a conventional syringe. * Local anesthesia with lidocaine plus adrenaline (1:100,000). * Tooth extraction.

Drug: 0.2% Chlorhexidine; Drug: 1% Chlorhexidine; Procedure: Blood extraction; Drug: Lidocaine plus adrenaline; Procedure: Tooth extraction

Interventions

0.2% Chlorhexidine DRUG

mouthwash with 10 ml for 1 minute

Also known as: OraldinePerio, Chlorhexidine 0.2%

CHX-MW/SUB_IR; CHX-MW/SUPRA_IR; CHX-Mouthwash

1% Chlorhexidine DRUG

subgingival irrigation

Also known as: Normosept 1g/100ml sloution, Chlorhexidine 1%

CHX-MW/SUB_IR

Blood extraction PROCEDURE

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

CHX-MW/SUB_IR; CHX-MW/SUPRA_IR; CHX-Mouthwash; Control

Lidocaine plus adrenaline DRUG

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

Also known as: anaesthesia

CHX-MW/SUB_IR; CHX-MW/SUPRA_IR; CHX-Mouthwash; Control

Tooth extraction PROCEDURE

dental extraction

CHX-MW/SUB_IR; CHX-MW/SUPRA_IR; CHX-Mouthwash; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with need for dental extraction

You may not qualify if:

• patients under 18 years of age
• antibiotic treatment in the previous three months
• routine use of oral antiseptics
• any type of congenital or acquired immunodeficiency or other disease that could favour the onset of infection or haemorrhagic complications

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (2)

Department of Stomatology and Maxillofacial Surgery of the Santo Antonio General Hospital

Porto, Porto District, 4099-001 PORTO, Portugal

Location

Department of Stomatology University of Santiago de Compostela

Santiago de Compostela, Galicia/A Coruña, 15782, Spain

Location

Related Publications (5)

• Tomas I, Alvarez M, Limeres J, Tomas M, Medina J, Otero JL, Diz P. Effect of a chlorhexidine mouthwash on the risk of postextraction bacteremia. Infect Control Hosp Epidemiol. 2007 May;28(5):577-82. doi: 10.1086/516663. Epub 2007 Apr 5.

  PMID: 17464918 BACKGROUND

• Tomas 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. doi: 10.1111/j.1601-0825.2006.01247.x.

  PMID: 17241431 BACKGROUND

• Benitez-Paez A, Alvarez M, Belda-Ferre P, Rubido S, Mira A, Tomas I. Detection of transient bacteraemia following dental extractions by 16S rDNA pyrosequencing: a pilot study. PLoS One. 2013;8(3):e57782. doi: 10.1371/journal.pone.0057782. Epub 2013 Mar 4.

  PMID: 23469240 BACKGROUND

• Pineiro A, Tomas I, Blanco J, Alvarez M, Seoane J, Diz P. Bacteraemia following dental implants' placement. Clin Oral Implants Res. 2010 Sep;21(9):913-8. doi: 10.1111/j.1600-0501.2010.01928.x.

  PMID: 20701619 BACKGROUND

• Barbosa M, Prada-Lopez I, Alvarez M, Amaral B, de los Angeles CD, Tomas I. Post-tooth extraction bacteraemia: a randomized clinical trial on the efficacy of chlorhexidine prophylaxis. PLoS One. 2015 May 8;10(5):e0124249. doi: 10.1371/journal.pone.0124249. eCollection 2015.

  PMID: 25955349 DERIVED

MeSH Terms

Conditions

Bacteremia

Interventions

Chlorhexidine; Solutions; Lidocaine; Epinephrine; Anesthesia; Tooth Extraction

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthesia and Analgesia; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Inmaculada Tomas

  Senior lecturer at University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 29, 2014
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

PT (1); ES (1)