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临床试验/NCT02215473
NCT02215473已完成4 期

Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial

University of Taubate1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年8月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Changes on viable bacterial levels in blood

研究概览

简要总结

Bacteremia represents the presence of live germs in the blood stream. Patients with gum disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily activities such as mastication can induce bacteremia in these patients. Dental procedures related to bleeding also induce bacteremia. However, there are many questions that should be clarified. Among them, clinical strategies that are able to reduce the levels of germs in blood should be determined. This desirable effect could be particularly important for some patients, for example, for those at higher risk for endocarditis. Therefore, this study tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental instrumentation could reduce the levels of bacteria in the blood. In addition, the occurrence and magnitude of bacteremia in patients with gum disease were investigated by two different laboratorial techniques. After receiving verbal and written explanations and after signed the informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse use and dental instrumentation and b) dental instrumentation with no mouth rinse. In a preliminary visit volunteers underwent a complete periodontal examination which included clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue and dental plaque samples collected with paper points), saliva (to determine volume and biological indicators) and gingival crevicular fluid sampling (to monitor gingival inflammation profile). In the next visit, dental instrumentation was performed under local anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant. Blood samples were collected before any dental procedure, 2 and 6 minutes after dental instrumentation. Oral hygiene instructions and periodontal treatment were performed in additional visits according to individual needs. Finally, the relation between bacteremia and several indicators of periodontal status was investigated.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • mild to moderate plaque related gingivitis (gingivitis group)
  • mild to moderate periodontitis (periodontitis group)
  • at least 20 natural teeth
  • with no recognized systemic risk related to bacteremia
  • no need for antibiotic prophylaxis before dental procedures

排除标准

  • systemic diseases or other conditions that could influence the periodontal status;
  • alcohol or other drugs abuse;
  • orthodontic devices;
  • extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
  • pregnancy or breast-feeding;
  • history of sensitivity or suspected allergies following the use of chlorhexidine;
  • antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
  • regular use of chemotherapeutic antiplaque/antigingivitis products;
  • any furcation lesions;
  • periodontal treatment performed within six months prior to study initiation;
  • unwillingness to return for follow-up.

研究组 & 干预措施

gingivitis mouth rinse

Experimental

干预措施: Chlorhexidine gluconate mouth rinse (Drug)

gingivitis mouth rinse

Experimental

干预措施: Periodontal instrumentation (Procedure)

periodontitis mouth rinse

Experimental

干预措施: Chlorhexidine gluconate mouth rinse (Drug)

periodontitis mouth rinse

Experimental

干预措施: Periodontal instrumentation (Procedure)

gingivitis no mouth rinse

Active Comparator

干预措施: Periodontal instrumentation (Procedure)

periodontitis no mouth rinse

Active Comparator

干预措施: Periodontal instrumentation (Procedure)

结局指标

主要结局

Changes on viable bacterial levels in blood

时间窗: 2 and 6 minutes

To check a possible antimicrobial effect after a single mouth rinse use, the levels of viable anaerobic and aerobic bacterial cels were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes. Blood samples were collected and spread out onto agar plates to determine total levels of aerobic and anaerobic bacteria. Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.

次要结局

  • Changes on levels of bacterial DNA in blood(2 and 6 months)

研究者

发起方
University of Taubate
申办方类型
Other
责任方
Sponsor

研究点 (1)

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