<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02215473</url>
  </required_header>
  <id_info>
    <org_study_id>BPP</org_study_id>
    <nct_id>NCT02215473</nct_id>
  </id_info>
  <brief_title>Bacteremia in Periodontal Patients</brief_title>
  <official_title>Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Taubate</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Taubate</source>
  <brief_summary>
    <textblock>
      Bacteremia represents the presence of live germs in the blood stream. Patients with gum&#xD;
      disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily&#xD;
      activities such as mastication can induce bacteremia in these patients. Dental procedures&#xD;
      related to bleeding also induce bacteremia. However, there are many questions that should be&#xD;
      clarified. Among them, clinical strategies that are able to reduce the levels of germs in&#xD;
      blood should be determined. This desirable effect could be particularly important for some&#xD;
      patients, for example, for those at higher risk for endocarditis. Therefore, this study&#xD;
      tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental&#xD;
      instrumentation could reduce the levels of bacteria in the blood. In addition, the occurrence&#xD;
      and magnitude of bacteremia in patients with gum disease were investigated by two different&#xD;
      laboratorial techniques. After receiving verbal and written explanations and after signed the&#xD;
      informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having&#xD;
      dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse&#xD;
      use and dental instrumentation and b) dental instrumentation with no mouth rinse. In a&#xD;
      preliminary visit volunteers underwent a complete periodontal examination which included&#xD;
      clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue&#xD;
      and dental plaque samples collected with paper points), saliva (to determine volume and&#xD;
      biological indicators) and gingival crevicular fluid sampling (to monitor gingival&#xD;
      inflammation profile). In the next visit, dental instrumentation was performed under local&#xD;
      anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant.&#xD;
      Blood samples were collected before any dental procedure, 2 and 6 minutes after dental&#xD;
      instrumentation. Oral hygiene instructions and periodontal treatment were performed in&#xD;
      additional visits according to individual needs. Finally, the relation between bacteremia and&#xD;
      several indicators of periodontal status was investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes on viable bacterial levels in blood</measure>
    <time_frame>2 and 6 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes on levels of bacterial DNA in blood</measure>
    <time_frame>2 and 6 months</time_frame>
    <description>To check a possible antimicrobial effect after a single mouth rinse use, the levels of bacterial DNA in blood samples were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes. Blood samples were collected and analyzed by real time PCR (polymerase chain reaction) to determine total bacterial load and levels of target periodontal pathogens. Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Gingivitis</condition>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>gingivitis mouth rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>periodontitis mouth rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>gingivitis no mouth rinse</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>periodontitis no mouth rinse</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine gluconate mouth rinse</intervention_name>
    <description>Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds). Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>gingivitis mouth rinse</arm_group_label>
    <arm_group_label>periodontitis mouth rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal instrumentation</intervention_name>
    <description>Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>gingivitis mouth rinse</arm_group_label>
    <arm_group_label>gingivitis no mouth rinse</arm_group_label>
    <arm_group_label>periodontitis mouth rinse</arm_group_label>
    <arm_group_label>periodontitis no mouth rinse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild to moderate plaque related gingivitis (gingivitis group)&#xD;
&#xD;
          -  mild to moderate periodontitis (periodontitis group)&#xD;
&#xD;
          -  at least 20 natural teeth&#xD;
&#xD;
          -  with no recognized systemic risk related to bacteremia&#xD;
&#xD;
          -  no need for antibiotic prophylaxis before dental procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases or other conditions that could influence the periodontal status;&#xD;
&#xD;
          -  alcohol or other drugs abuse;&#xD;
&#xD;
          -  orthodontic devices;&#xD;
&#xD;
          -  extended prosthetic fixed devices, removable partial dentures or overhanging&#xD;
             restorations;&#xD;
&#xD;
          -  pregnancy or breast-feeding;&#xD;
&#xD;
          -  history of sensitivity or suspected allergies following the use of chlorhexidine;&#xD;
&#xD;
          -  antibiotics and/or anti-inflammatory drug use in the three months prior to the&#xD;
             beginning of the study;&#xD;
&#xD;
          -  regular use of chemotherapeutic antiplaque/antigingivitis products;&#xD;
&#xD;
          -  any furcation lesions;&#xD;
&#xD;
          -  periodontal treatment performed within six months prior to study initiation;&#xD;
&#xD;
          -  unwillingness to return for follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose R Cortelli, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Taubate</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nucleus of periodontal research of University of Taubate</name>
      <address>
        <city>Taubate</city>
        <state>SP</state>
        <zip>12020330</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gingivitis</keyword>
  <keyword>periodontitis</keyword>
  <keyword>mouth rinse</keyword>
  <keyword>bacteremia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02215473
org study id: BPP
nct id: NCT02215473
lead sponsor: 
collaborator: 
collaborator: 
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes on viable bacterial levels in blood
time frame: 2 and 6 minutes
description: 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.
measure: Changes on levels of bacterial DNA in blood
time frame: 2 and 6 months
description: To check a possible antimicrobial effect after a single mouth rinse use, the levels of bacterial DNA in blood samples were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes. Blood samples were collected and analyzed by real time PCR (polymerase chain reaction) to determine total bacterial load and levels of target periodontal pathogens. Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.
arm group label: gingivitis mouth rinse
arm group type: Experimental
arm group label: periodontitis mouth rinse
arm group type: Experimental
arm group label: gingivitis no mouth rinse
arm group type: Active Comparator
arm group label: periodontitis no mouth rinse
arm group type: Active Comparator
intervention type: Drug
intervention name: Chlorhexidine gluconate mouth rinse
description: Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds). Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
arm group label: gingivitis mouth rinse
arm group label: periodontitis mouth rinse
intervention type: Procedure
intervention name: Periodontal instrumentation
description: Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
arm group label: gingivitis mouth rinse
arm group label: gingivitis no mouth rinse
arm group label: periodontitis mouth rinse
arm group label: periodontitis no mouth rinse
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Jose R Cortelli, PhD
role: Principal Investigator
affiliation: University of Taubate
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Gingivitis
mesh term: Bacteremia
mesh term: Periodontitis
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate