<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/NCT02988349</url>
  </required_header>
  <id_info>
    <org_study_id>WCHSIRB-D-2013-067-R2</org_study_id>
    <nct_id>NCT02988349</nct_id>
  </id_info>
  <brief_title>Ecological Effect of Arginine Dentifrice on Oral Microbiota</brief_title>
  <official_title>Ecological Effect of 8% Arginine Dentifrice on Oral Microbiota of Caries-Free and Caries-active Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sichuan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited.&#xD;
      Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate®&#xD;
      Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks.&#xD;
      Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before&#xD;
      and after the treatment for laboratory analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      21 caries-free (CF) individuals with no clinical evidence of caries experience [decayed,&#xD;
      missing and filled teeth (DMFT) = 0] and 21 caries-active (CA) individuals (DMFT ≥ 6) will be&#xD;
      recruited in the clinical trial. The exclusion criteria are: smoker or former smoker,&#xD;
      presence of any systemic disease that could alter the production or composition of saliva,&#xD;
      treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3&#xD;
      months, and presence of dental prostheses or orthodontic devices. Subjects will be instructed&#xD;
      to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste&#xD;
      (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Volunteers are asked to refrain from&#xD;
      brushing and flossing their teeth, eating, and drinking anything other than water for 12 h&#xD;
      prior to sample collection visits at the end of both phases. Supra- and subgingival plaque&#xD;
      (15 subjects in each group), saliva (21 subjects in each group), and in situ plaque samples&#xD;
      (3 subjects in each group) will be collected before and after the treatment. Scraped plaque&#xD;
      and saliva samples will be immediately transferred to and dispersed in sterile&#xD;
      micro-centrifuge tubes containing 1×phosphate-buffered saline (PBS), and stored at -80 °C&#xD;
      until needed for analysis. The in situ plaque samples will be transferred into 4%&#xD;
      paraformaldehyde, kept under 4 °C for 16 h, and then stored in 50% (v/v) ethanol at -20 °C.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing</measure>
    <time_frame>baseline , 2 week</time_frame>
    <description>Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays</measure>
    <time_frame>baseline ,2 week</time_frame>
    <description>Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Dental Caries</condition>
  <condition>Oral Bacterial Infection</condition>
  <condition>Microbiota</condition>
  <arm_group>
    <arm_group_label>Caries-free subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caries-active subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colgate® Sensitive Pro-Relief® toothpaste</intervention_name>
    <description>Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
    <arm_group_label>Caries-active subjects</arm_group_label>
    <arm_group_label>Caries-free subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caries-free individuals with no clinical evidence of caries experience [decayed,&#xD;
             missing and filled teeth (DMFT) = 0] and caries-active individuals (DMFT ≥ 6) were&#xD;
             recruited&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoker or former smoker, presence of any systemic disease that could alter the&#xD;
             production or composition of saliva, treatment with antibiotics, steroids or any&#xD;
             medication known to cause dry mouth in the last 3 months, and presence of dental&#xD;
             prostheses or orthodontic devices.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Xu, D.D.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital of Stomatology, Sichuan University</affiliation>
  </overall_official>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>April 24, 2017</results_first_submitted>
  <results_first_submitted_qc>April 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2018</results_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sichuan University</investigator_affiliation>
    <investigator_full_name>Xin Xu</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first recruitment took place on Oct. 2013, in the Department of Operative Dentistry and Endodontics, West China Hospital of Stomatology. 15 CF and 15 CA individuals were recruited by the end of Nov. 2013.&#xD;
The second recruitment took place on May in the same location. 2014. 6 CF and 6 CA individuals were recruited by the end of Jun. 2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Caries-free Subjects</title>
          <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Caries-active Subjects</title>
          <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Caries-free Subjects</title>
          <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Caries-active Subjects</title>
          <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" lower_limit="19" upper_limit="31"/>
                    <measurement group_id="B2" value="23" lower_limit="19" upper_limit="28"/>
                    <measurement group_id="B3" value="23" lower_limit="19" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing</title>
        <description>Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.</description>
        <time_frame>baseline , 2 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Caries-free Subjects</title>
            <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Caries-active Subjects</title>
            <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing</title>
          <description>Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.</description>
          <units>percentage of bacteria</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline: sm in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00756" spread="0.00726"/>
                    <measurement group_id="O2" value="0.14636" spread="0.23221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: sm in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00629" spread="0.00835"/>
                    <measurement group_id="O2" value="0.11956" spread="0.20686"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: sm in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00608" spread="0.00575"/>
                    <measurement group_id="O2" value="0.01314" spread="0.01272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: ss in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.007766667" spread="1.168793223"/>
                    <measurement group_id="O2" value="0.521506667" spread="0.511640082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: ss in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.064646667" spread="2.595662011"/>
                    <measurement group_id="O2" value="1.539913333" spread="1.369851357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline: ss in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.812706667" spread="1.040344461"/>
                    <measurement group_id="O2" value="0.18324" spread="0.199811864"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: sm in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003406667" spread="0.003320384"/>
                    <measurement group_id="O2" value="0.009526667" spread="0.011458775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: sm in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0033" spread="0.006143173"/>
                    <measurement group_id="O2" value="0.00284" spread="0.005101792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: sm in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002493333" spread="0.004110347"/>
                    <measurement group_id="O2" value="0.003006667" spread="0.002304488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: ss in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.655106667" spread="1.274066247"/>
                    <measurement group_id="O2" value="3.21486" spread="3.436273455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: ss in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.588546667" spread="4.92217214"/>
                    <measurement group_id="O2" value="3.232233333" spread="3.336652867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: ss in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3109" spread="0.885269549"/>
                    <measurement group_id="O2" value="2.040286667" spread="3.369773515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays</title>
        <description>Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.</description>
        <time_frame>baseline ,2 week</time_frame>
        <population>Among the 21 participants in each group，we only measured the enzyme activity from randomly choosed 15 participants from each group.</population>
        <group_list>
          <group group_id="O1">
            <title>Caries-free Subjects</title>
            <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Caries-active Subjects</title>
            <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays</title>
          <description>Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.</description>
          <population>Among the 21 participants in each group，we only measured the enzyme activity from randomly choosed 15 participants from each group.</population>
          <units>enzyme activity (μmol/min/g)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline: ADS activity in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8945" spread="0.13310"/>
                    <measurement group_id="O2" value="0.3653" spread="0.06108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: ADS activity in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63150" spread="0.08604"/>
                    <measurement group_id="O2" value="0.29110" spread="0.04347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: ADS activity in saliva plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75870" spread="0.09211"/>
                    <measurement group_id="O2" value="0.23470" spread="0.03328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: urease activity in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6795" spread="0.11518"/>
                    <measurement group_id="O2" value="0.3207" spread="0.06317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: urease activity in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71840" spread="0.08770"/>
                    <measurement group_id="O2" value="0.34630" spread="0.04611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: urease activity in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72900" spread="0.66210"/>
                    <measurement group_id="O2" value="0.17920" spread="0.03047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: LDH activity in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.859050" spread="0.6648584"/>
                    <measurement group_id="O2" value="20.965090" spread="1.549900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: LDH activity in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.267220" spread="0.2555969"/>
                    <measurement group_id="O2" value="17.576110" spread="0.887500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>baseline: LDH activity in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.508787" spread="0.8707994"/>
                    <measurement group_id="O2" value="16.053870" spread="2.361490"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: ADS activity in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0771" spread="0.23754"/>
                    <measurement group_id="O2" value="0.8418" spread="0.13711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: ADS activity in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74650" spread="0.10275"/>
                    <measurement group_id="O2" value="0.73600" spread="0.07218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: ADS activity in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77410" spread="0.11136"/>
                    <measurement group_id="O2" value="0.34850" spread="0.04391"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: urease activity in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5871" spread="0.07970"/>
                    <measurement group_id="O2" value="0.6508" spread="0.10083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: urease activity in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73330" spread="0.06165"/>
                    <measurement group_id="O2" value="0.69680" spread="0.08427"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: urease activity in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73240" spread="0.05464"/>
                    <measurement group_id="O2" value="0.25260" spread="0.04560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: LDH activity in supragingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.347060" spread="0.9240766"/>
                    <measurement group_id="O2" value="14.096910" spread="0.3565668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: LDH activity in subgingival plaque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.664124" spread="0.8184378"/>
                    <measurement group_id="O2" value="11.649030" spread="1.135210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 week: LDH activity in saliva</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.496731" spread="0.1797688"/>
                    <measurement group_id="O2" value="15.268450" spread="0.3687766"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Caries-free Subjects</title>
          <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Caries-active Subjects</title>
          <description>Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.&#xD;
Colgate® Sensitive Pro-Relief® toothpaste: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Xin Xu</name_or_title>
      <organization>Sichuan University</organization>
      <phone>86-28-85503494</phone>
      <email>xin.xu@scu.edu.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02988349
org study id: WCHSIRB-D-2013-067-R2
nct id: NCT02988349
lead sponsor: 
has dmc: No
caries-free (CF) individuals caries-active (CA) individuals (DMFT ≥ 6) will be recruited.
      Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate®
      Sensitive Pro-Relief® toothpaste (containing 8% arginine and 1450 ppm NaF) for 2 weeks.
      Supra- and subgingival plaque, saliva, and in situ plaque samples will be collected before
      and after the treatment for laboratory analyses.
21 caries-free (CF) individuals with no clinical evidence of caries experience [decayed,
      missing and filled teeth (DMFT) = 0] and 21 caries-active (CA) individuals (DMFT ≥ 6) will be
      recruited in the clinical trial. The exclusion criteria are: smoker or former smoker,
      presence of any systemic disease that could alter the production or composition of saliva,
      treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3
      months, and presence of dental prostheses or orthodontic devices. Subjects will be instructed
      to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste
      (containing 8% arginine and 1450 ppm NaF) for 2 weeks. Volunteers are asked to refrain from
      brushing and flossing their teeth, eating, and drinking anything other than water for 12 h
      prior to sample collection visits at the end of both phases. Supra- and subgingival plaque
      (15 subjects in each group), saliva (21 subjects in each group), and in situ plaque samples
      (3 subjects in each group) will be collected before and after the treatment. Scraped plaque
      and saliva samples will be immediately transferred to and dispersed in sterile
      micro-centrifuge tubes containing 1×phosphate-buffered saline (PBS), and stored at -80 °C
      until needed for analysis. The in situ plaque samples will be transferred into 4%
      paraformaldehyde, kept under 4 °C for 16 h, and then stored in 50% (v/v) ethanol at -20 °C.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing
time frame: baseline , 2 week
description: Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.
measure: The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays
time frame: baseline ,2 week
description: Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.
arm group label: Caries-free subjects
arm group type: Active Comparator
description: Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
arm group label: Caries-active subjects
arm group type: Experimental
description: Subjects will use Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks,.
intervention type: Other
intervention name: Colgate® Sensitive Pro-Relief® toothpaste
description: Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
arm group label: Caries-active subjects
arm group label: Caries-free subjects
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xin Xu, D.D.S
role: Principal Investigator
affiliation: West China Hospital of Stomatology, Sichuan University
responsible party type: Principal Investigator
investigator affiliation: Sichuan University
investigator full name: Xin Xu
investigator title: Clinical Professor
mesh term: Bacterial Infections
mesh term: Dental Caries
mesh term: Listerine
mesh term: Sodium Fluoride
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 