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Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols

Primary Purpose

Bacteremia, Tooth Extraction Status Nos

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
0.2% Chlorhexidine
1% Chlorhexidine
1% Chlorhexidine
Blood extraction
Lidocaine plus adrenaline
Tooth extraction
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacteremia focused on measuring prevention and control, chlorhexidine, therapeutic irrigation, mouthwashes, culture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • with need for dental extraction

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Stomatology and Maxillofacial Surgery of the Santo Antonio General Hospital
  • Department of Stomatology University of Santiago de Compostela

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

CHX-Mouthwash

CHX-MW/SUB_IR

CHX-MW/SUPRA_IR

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2014
Last Updated
May 25, 2014
Sponsor
University of Santiago de Compostela
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1. Study Identification

Unique Protocol Identification Number
NCT02150031
Brief Title
Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols
Official Title
Bacteraemia Secondary to Tooth Extraction: a Randomized Clinical Trial on Efficacy of Three Different Chlorhexidine Prophylaxis Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study group will be formed of patients undergoing tooth extraction under local anaesthesia in the Department of Stomatology and Maxillofacial Surgery of the Santo Antonio General Hospital (Oporto, Portugal).The following exclusion criteria will be applied: patients under 18 years of age; antibiotic treatment in the previous three months; routine use of oral antiseptics; and any type of congenital or acquired immunodeficiency or other disease that can favour the onset of infection or haemorrhagic complications. Applying these criteria and after a statistic power test, the sample will be 208 patients. The select patients will be attributed randomly a number of participation and they will be distributed into four groups: Control Group: 52 patients who will use no prophylactic chlorhexidine (CHX) regimen. CHX mouthwash group (CHX-MW group): 52 patients who will perform a mouthwash with 0.2% CHX (10 ml for 1 minute, BSAC recommendations) (Oraldine Perio®, Johnson and Johnson, Barcelona, Spain) before the tooth extraction. CHX mouthwash/subgingival irrigation group (CHX-MW/SUB_IR group): 52 patients who will perform a mouthwash with 0.2% CHX (10 ml for 1 minute) (Oraldine Perio®) and who then will undergo subgingival irrigation with 1% CHX on the tooth to be extracted; the irrigation will be done with the Heraeus Citojet Intraligamental Syringe (CIS) (Kulzer Heraeus S.A., Madrid, Spain) at six points on each tooth (3 points on the vestibular surface and 3 on the palatine surface). CHX mouthwash/supragingival irrigation group (CHX-MW/SUPRA_IR group): 52 patients who will perform a mouthwash with 0.2% CHX (10 ml for 1 minute) (Oraldine Perio®) and who then will undergo supragingival irrigation with 1% CHX on the tooth to be extracted; the irrigation will be done continuously around the tooth to be extracted by a conventional syringe. The mouthwash and subgingival or supragingival irrigation will be performed before injection of the local anaesthetic. After recording the sex and age of each patient, a single dentist will perform an intraoral examination 2 days before the intervention, collecting the following information: plaque deposits (simplified Greene and Vermillion oral hygiene index) , calculus deposits (Ramfjord calculus index), presence of gingival bleeding (Löe and Silness gingival index), depth of periodontal pockets (Ramfjord index), degree of tooth mobility (Ramfjord tooth mobility index), number of caries (including root remnants), and presence of submucosal abscesses, fistulae and periapical foci detected clinically and/or radiologically. Each patient will be assigned an overall oral health status using a scale designed by the authors and published previously; the scale incorporates dental and periodontal health criteria. Local anaesthesia will be administered to all patients using conventional techniques (regional block and/or infiltration). The anaesthetic will be lidocaine plus adrenaline (1:100,000) and not more than 2 cartridges in any patient. The prevalence of baseline bacteraemia will be determined by collection of a peripheral venous blood sample (10 ml) from each patient before performing any manipulation. The prevalence of bacteraemia secondary to a mouthwash and subgingival or supragingival irrigation will be determined by the collection of a peripheral blood sample (10 ml) 30 seconds after each of these actions. Further samples (10 ml) will be drawn 30 seconds and 15 minutes after completion of the tooth extraction in order to determine the prevalence and duration of post-extraction bacteraemia. Intravenous access will established using an 18-22 gauge "angiocath" catheter (Becton Dickinson, Sparks, MD, USA) inserted in the antecubital fossa or dorsum of the hand after disinfection of the area with alcohol and povidone iodine. The catheter will be flushed with 3 ml of saline after each extraction and the first 2 ml of blood was discarded. Equal volumes of each sample will be inoculated into two bottles containing aerobic and anaerobic culture media (Bactec Plus, Becton Dickinson), and the bottles will be immediately transferred to the laboratory. The whole process of manipulation and transport of the samples will be performed in accordance with the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology. The blood culture bottles into which the blood samples will be injected and processed in the Bactec 9240 (Becton Dickinson). Gram stain will be performed on all positive cultures. The positive aerobic blood cultures will be subcultured on blood agar and chocolate agar in an atmosphere with 5%-10% CO2, and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive anaerobic blood cultures but include subculture on Schaedler agar and incubation under anaerobic conditions. The bacteria isolated will be identified using the battery of biochemical tests provided by the Vitek system (bioMérieux Inc., Hazelwood, Missouri, USA) for gram-positive bacteria, Neisseria spp./Haemophilus spp. and obligate anaerobic bacteria. Applying the Ruoff criteria, Streptococcus viridans will be classified into five groups: mutans, salivarius, bovis, anginosus and mitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia, Tooth Extraction Status Nos
Keywords
prevention and control, chlorhexidine, therapeutic irrigation, mouthwashes, culture

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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.
Arm Title
CHX-Mouthwash
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CHX-MW/SUB_IR
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CHX-MW/SUPRA_IR
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.2% Chlorhexidine
Other Intervention Name(s)
OraldinePerio, Chlorhexidine 0.2%
Intervention Description
mouthwash with 10 ml for 1 minute
Intervention Type
Drug
Intervention Name(s)
1% Chlorhexidine
Other Intervention Name(s)
Normosept 1g/100ml sloution, Chlorhexidine 1%
Intervention Description
subgingival irrigation
Intervention Type
Drug
Intervention Name(s)
1% Chlorhexidine
Other Intervention Name(s)
Normosept 1g/100ml solution, Chlorhexidine 1%
Intervention Description
supragingival irrigation
Intervention Type
Procedure
Intervention Name(s)
Blood extraction
Intervention Description
Blood extraction using an intravenous access at baseline, 30 seconds after antiseptic aplication, 30 seconds and 15 minutes after tooth extraction.
Intervention Type
Drug
Intervention Name(s)
Lidocaine plus adrenaline
Other Intervention Name(s)
anaesthesia
Intervention Description
local anaesthesia using lidocaine plus adrenaline (1:100,000) no more than 2 cartridges.
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction
Intervention Description
dental extraction
Primary Outcome Measure Information:
Title
Changes in the prevalence of bacteraemia
Description
Presence of bacteria and how long it lasts in the blood stream.
Time Frame
before and 30 seconds after the antiseptic aplication and 30 seconds and 15 minutes after dental extraction.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: with need for dental extraction Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomas
Organizational Affiliation
Senior lecturer at University of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Stomatology and Maxillofacial Surgery of the Santo Antonio General Hospital
City
Oporto
ZIP/Postal Code
4099-001 PORTO
Country
Portugal
Facility Name
Department of Stomatology University of Santiago de Compostela
City
Santiago de Compostela
State/Province
Galicia/A Coruña
ZIP/Postal Code
15782
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17464918
Citation
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.
Results Reference
background
PubMed Identifier
17241431
Citation
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.
Results Reference
background
PubMed Identifier
23469240
Citation
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.
Results Reference
background
PubMed Identifier
20701619
Citation
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.
Results Reference
background
PubMed Identifier
25955349
Citation
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.
Results Reference
derived

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Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols

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