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临床试验/NCT02150031
NCT02150031已完成4 期

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

University of Santiago de Compostela2 个研究点 分布在 2 个国家目标入组 208 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
208
试验地点
2
主要终点
Changes in the prevalence of bacteraemia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • with need for dental extraction

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Blood extraction (Procedure)

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.

干预措施: Lidocaine plus adrenaline (Drug)

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.

干预措施: Tooth extraction (Procedure)

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.

干预措施: 0.2% Chlorhexidine (Drug)

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.

干预措施: Blood extraction (Procedure)

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.

干预措施: Lidocaine plus adrenaline (Drug)

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.

干预措施: Tooth extraction (Procedure)

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.

干预措施: 0.2% Chlorhexidine (Drug)

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.

干预措施: 1% Chlorhexidine (Drug)

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.

干预措施: Blood extraction (Procedure)

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.

干预措施: Lidocaine plus adrenaline (Drug)

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.

干预措施: Tooth extraction (Procedure)

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.

干预措施: 0.2% Chlorhexidine (Drug)

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.

干预措施: 1% Chlorhexidine (Drug)

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.

干预措施: Blood extraction (Procedure)

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.

干预措施: Lidocaine plus adrenaline (Drug)

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.

干预措施: Tooth extraction (Procedure)

结局指标

主要结局

Changes in the prevalence of bacteraemia

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inmaculada Tomas

Senior lecturer

University of Santiago de Compostela

研究点 (2)

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