<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/NCT02999230</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201602471-N</org_study_id>
    <secondary_id>5R01DE025832-05</secondary_id>
    <nct_id>NCT02999230</nct_id>
  </id_info>
  <brief_title>Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health</brief_title>
  <official_title>Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the mechanisms of action of probiotics and synbiotics for control of&#xD;
      oral diseases, with a particular focus on exploring new strategies for caries prevention and&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects recruited in years 1, 2, and 4 will only be seen for one study visit and will follow&#xD;
      the research visit protocol listed below:&#xD;
&#xD;
      Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked&#xD;
      to fill out a study registration form and an oral habits/medical history form. They will be&#xD;
      asked to sign an Informed Consent. The subject will then have their teeth and gums examined.&#xD;
      At this visit, the investigator will assess whether or not the subject is a good candidate&#xD;
      for the study. During the phone interview each subject was asked not to brush or floss their&#xD;
      teeth and not to eat or drink anything other than water for 8 hours prior to the&#xD;
      pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples&#xD;
      will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline).&#xD;
      If not, they will be asked to return to the clinic for another visit and asked not to brush&#xD;
      or floss their teeth and not to eat or drink anything other than water 8 hours prior to that&#xD;
      appointment. This visit will then be consider Visit 1 (Baseline).&#xD;
&#xD;
      Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They&#xD;
      will have their teeth and gums examined. Saliva and plaque will be collected. This will be&#xD;
      the end of the study for subjects recruited in years 1, 2, and 4.&#xD;
&#xD;
      Subjects will be grouped by the year they participate in the study. Subjects recruited in&#xD;
      year 3 will follow the research visit protocol outlined below:&#xD;
&#xD;
      Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked&#xD;
      to fill out a study registration form and an oral habits/medical history form. They will be&#xD;
      asked to sign an Informed Consent. The subject will then have their teeth and gums examined.&#xD;
      At this visit, the investigator will assess whether or not the subject is a good candidate&#xD;
      for the study. During the phone interview each subject was asked not to brush or floss their&#xD;
      teeth and not to eat or drink anything other than water for 8 hours prior to the&#xD;
      pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples&#xD;
      will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline).&#xD;
      If not, they will be asked to return to the clinic for another visit and asked not to brush&#xD;
      or floss their teeth and not to eat or drink anything other than water 8 hours prior to that&#xD;
      appointment. This visit will then be considered Visit 1 (Baseline).&#xD;
&#xD;
      Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They&#xD;
      will have their teeth and gums examined. Saliva and plaque will be collected. Each subject&#xD;
      will be given a toothbrush and toothpaste and instructed to not use any other dental&#xD;
      products. This will be considered the &quot;washout&quot; period.&#xD;
&#xD;
      Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental&#xD;
      history will be reviewed and they will have their teeth examined. Saliva and plaque will be&#xD;
      collected at this visit. The subjects will then be randomly assigned (by chance, like the&#xD;
      flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to&#xD;
      the group that will use a marketed arginine containing toothpaste. The subject will also be&#xD;
      instructed not to brush or floss their teeth or eat or drink anything other than water for 8&#xD;
      hours prior to the next appointment.&#xD;
&#xD;
      Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or&#xD;
      drink anything other than water 8 hours prior to these visits. Saliva and plaque will be&#xD;
      collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At&#xD;
      this time participation in this research study will end and they will be instructed to return&#xD;
      to their regular oral hygiene regiments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Actual">June 5, 2022</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2</measure>
    <time_frame>Changes from baseline to 2 weeks (Screening)</time_frame>
    <description>Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4</measure>
    <time_frame>Changes from week 2 to week 4 (Baseline)</time_frame>
    <description>Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8</measure>
    <time_frame>Changes from week 4 to week 8 (Washout)</time_frame>
    <description>Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12</measure>
    <time_frame>Changes from week 8 to week 12 (Evaluation)</time_frame>
    <description>Saliva and dental plaque will be collected during the week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.</measure>
    <time_frame>Changes from baseline to week 12 (Evaluation)</time_frame>
    <description>Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2</measure>
    <time_frame>Changes from baseline to week 2</time_frame>
    <description>Saliva and dental plaque will be collected during the baseline and week 2 study visits.Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4</measure>
    <time_frame>Changes from week 2 to week 4</time_frame>
    <description>Saliva and dental plaque will be collected during the week 2 and week 4 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8</measure>
    <time_frame>Changes from week 4 to week 8</time_frame>
    <description>Saliva and dental plaque will be collected during the week 4 to week 8 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12</measure>
    <time_frame>Changes from week 8 to week 12</time_frame>
    <description>Saliva and dental plaque will be collected during the week 8 and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12</measure>
    <time_frame>Changes from baseline to week 12</time_frame>
    <description>Saliva and dental plaque will be collected during the baseline and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Salivary factors present in healthy and caries-active subjects during the research study.</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Saliva will be collected from healthy and caries-active subjects during the research study. The differences in salivary factors between the healthy and caries-active groups will be compared.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Caries Free</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caries Free- Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caries Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caries Active- Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caries Free 1.5% Arginine</intervention_name>
    <description>Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.</description>
    <arm_group_label>Caries Free</arm_group_label>
    <other_name>1.5% Arginine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caries Free Placebo Sodium Fluoride</intervention_name>
    <description>Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.</description>
    <arm_group_label>Caries Free- Placebo</arm_group_label>
    <other_name>Sodium Fluoride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caries Active 1.5% Arginine</intervention_name>
    <description>Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.</description>
    <arm_group_label>Caries Active</arm_group_label>
    <other_name>1.5% Arginine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caries Active- Placebo Sodium Fluoride</intervention_name>
    <description>Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.</description>
    <arm_group_label>Caries Active- Placebo</arm_group_label>
    <other_name>Sodium Fluoride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Twenty natural uncrowned teeth excluding third molars&#xD;
&#xD;
          -  No contraindications to dental treatment&#xD;
&#xD;
          -  Caries Free-(with no clinical evidence of past or present caries)&#xD;
&#xD;
          -  Caries Active- (At least two active sites)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 20 teeth&#xD;
&#xD;
          -  Systemic disease that can cause xerostomia&#xD;
&#xD;
          -  Taking medication known to cause xerostomia&#xD;
&#xD;
          -  Have been treated with antibiotics within the past 3 months&#xD;
&#xD;
          -  Advanced periodontal disease&#xD;
&#xD;
          -  Removable or fixed dental appliances&#xD;
&#xD;
          -  Bleeding disorders or taking anticoagulant medications&#xD;
&#xD;
          -  Immune compromised individuals&#xD;
&#xD;
          -  Uses tobacco products&#xD;
&#xD;
          -  Participation in another clinical study one week prior to the start of the washout&#xD;
             period or during the study period&#xD;
&#xD;
          -  Use of any flavored products, such as mint flavored candies and chewing gum, one week&#xD;
             prior to or during the study&#xD;
&#xD;
          -  Unwilling or unable to provide informed consent and follow plaque/saliva collection&#xD;
             instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelle Nascimento, DDS, MS PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida College of Dentistry</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>May 31, 2023</last_update_submitted>
  <last_update_submitted_qc>May 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cavities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02999230
org study id: IRB201602471-N
secondary id: 5R01DE025832-05
nct id: NCT02999230
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the mechanisms of action of probiotics and synbiotics for control of
      oral diseases, with a particular focus on exploring new strategies for caries prevention and
      treatment.
Subjects recruited in years 1, 2, and 4 will only be seen for one study visit and will follow
      the research visit protocol listed below:

      Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked
      to fill out a study registration form and an oral habits/medical history form. They will be
      asked to sign an Informed Consent. The subject will then have their teeth and gums examined.
      At this visit, the investigator will assess whether or not the subject is a good candidate
      for the study. During the phone interview each subject was asked not to brush or floss their
      teeth and not to eat or drink anything other than water for 8 hours prior to the
      pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples
      will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline).
      If not, they will be asked to return to the clinic for another visit and asked not to brush
      or floss their teeth and not to eat or drink anything other than water 8 hours prior to that
      appointment. This visit will then be consider Visit 1 (Baseline).

      Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They
      will have their teeth and gums examined. Saliva and plaque will be collected. This will be
      the end of the study for subjects recruited in years 1, 2, and 4.

      Subjects will be grouped by the year they participate in the study. Subjects recruited in
      year 3 will follow the research visit protocol outlined below:

      Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked
      to fill out a study registration form and an oral habits/medical history form. They will be
      asked to sign an Informed Consent. The subject will then have their teeth and gums examined.
      At this visit, the investigator will assess whether or not the subject is a good candidate
      for the study. During the phone interview each subject was asked not to brush or floss their
      teeth and not to eat or drink anything other than water for 8 hours prior to the
      pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples
      will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline).
      If not, they will be asked to return to the clinic for another visit and asked not to brush
      or floss their teeth and not to eat or drink anything other than water 8 hours prior to that
      appointment. This visit will then be considered Visit 1 (Baseline).

      Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They
      will have their teeth and gums examined. Saliva and plaque will be collected. Each subject
      will be given a toothbrush and toothpaste and instructed to not use any other dental
      products. This will be considered the "washout" period.

      Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental
      history will be reviewed and they will have their teeth examined. Saliva and plaque will be
      collected at this visit. The subjects will then be randomly assigned (by chance, like the
      flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to
      the group that will use a marketed arginine containing toothpaste. The subject will also be
      instructed not to brush or floss their teeth or eat or drink anything other than water for 8
      hours prior to the next appointment.

      Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or
      drink anything other than water 8 hours prior to these visits. Saliva and plaque will be
      collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At
      this time participation in this research study will end and they will be instructed to return
      to their regular oral hygiene regiments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2
time frame: Changes from baseline to 2 weeks (Screening)
description: Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
measure: Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
time frame: Changes from week 2 to week 4 (Baseline)
description: Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
measure: Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8
time frame: Changes from week 4 to week 8 (Washout)
description: Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
measure: Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12
time frame: Changes from week 8 to week 12 (Evaluation)
description: Saliva and dental plaque will be collected during the week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols
measure: Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
time frame: Changes from baseline to week 12 (Evaluation)
description: Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
measure: Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2
time frame: Changes from baseline to week 2
description: Saliva and dental plaque will be collected during the baseline and week 2 study visits.Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
measure: Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4
time frame: Changes from week 2 to week 4
description: Saliva and dental plaque will be collected during the week 2 and week 4 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
measure: Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8
time frame: Changes from week 4 to week 8
description: Saliva and dental plaque will be collected during the week 4 to week 8 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
measure: Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12
time frame: Changes from week 8 to week 12
description: Saliva and dental plaque will be collected during the week 8 and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
measure: Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12
time frame: Changes from baseline to week 12
description: Saliva and dental plaque will be collected during the baseline and week 12 study visits. Bacteria present in these oral samples will be isolated and identified. The capacity of the bacteria to produce ammonia from arginine in different environmental conditions will be measured.
measure: Salivary factors present in healthy and caries-active subjects during the research study.
time frame: Up to 6 months
description: Saliva will be collected from healthy and caries-active subjects during the research study. The differences in salivary factors between the healthy and caries-active groups will be compared.
arm group label: Caries Free
arm group type: Active Comparator
description: Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.
arm group label: Caries Free- Placebo
arm group type: Placebo Comparator
description: Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.
arm group label: Caries Active
arm group type: Active Comparator
description: Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.
arm group label: Caries Active- Placebo
arm group type: Placebo Comparator
description: Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.
intervention type: Other
intervention name: Caries Free 1.5% Arginine
description: Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
arm group label: Caries Free
other name: 1.5% Arginine
intervention type: Other
intervention name: Caries Free Placebo Sodium Fluoride
description: Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
arm group label: Caries Free- Placebo
other name: Sodium Fluoride
intervention type: Other
intervention name: Caries Active 1.5% Arginine
description: Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
arm group label: Caries Active
other name: 1.5% Arginine
intervention type: Other
intervention name: Caries Active- Placebo Sodium Fluoride
description: Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
arm group label: Caries Active- Placebo
other name: Sodium Fluoride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcelle Nascimento, DDS, MS PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dental Caries
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
sharing ipd: No