<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/NCT03296657</url>
  </required_header>
  <id_info>
    <org_study_id>CSD2017123</org_study_id>
    <nct_id>NCT03296657</nct_id>
  </id_info>
  <brief_title>Analysis of Stannous Fluoride in GCF and Subgingival Plaque</brief_title>
  <official_title>A Pilot Study to Evaluate Stannous Fluoride in GCF and Subgingival Plaque</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Procter and Gamble</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Procter and Gamble</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is pilot study involving approximately 20 subjects with at least 20 dental pockets&#xD;
      between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as&#xD;
      &quot;sampling sites&quot; that will have supragingival plaque, subgingival plaque, and gingival&#xD;
      crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">September 22, 2017</completion_date>
  <primary_completion_date type="Actual">September 22, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of tin in GCF sample</measure>
    <time_frame>mean difference from 30 minutes to baseline</time_frame>
    <description>per GCF sample amount of stannous level in ng/uL will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Amount of tin in GCF and Subgingival Plaque</measure>
    <time_frame>change from visit (change from 24 hours to baseline, change Week 2 to baseline)</time_frame>
    <description>stannous level in subgingival plaque will be measured as concentration in ng, per GCF sample amount of stannous level in ng/uL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Subgingival Plaque</condition>
  <condition>GCF</condition>
  <arm_group>
    <arm_group_label>stannous fluoride toothpaste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>stannous fluoride</intervention_name>
    <description>subjects will brush with paste twice daily for 2 weeks</description>
    <arm_group_label>stannous fluoride toothpaste</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent to participate in the study;&#xD;
&#xD;
          -  Be 18 years of age or older;&#xD;
&#xD;
          -  Agree not to participate in any other oral/dental product studies during the course of&#xD;
             this study;&#xD;
&#xD;
          -  Agree to delay any elective dentistry (including dental prophylaxis) until the study&#xD;
             has been completed;&#xD;
&#xD;
          -  Agree to use the acclimation products and to refrain from using any other oral care&#xD;
             products (including floss and mouth rinse) between the Acclimation and Baseline Visit;&#xD;
&#xD;
          -  Agree to use the treatment products and refrain from any form of non-specified oral&#xD;
             hygiene during the treatment periods (after the Baseline Visit), including but not&#xD;
             limited to the use of products such as floss, mouth rinse, or whitening products;&#xD;
&#xD;
          -  Agree to return for all scheduled visits and follow study procedures;&#xD;
&#xD;
          -  Must have at least 16 natural teeth;&#xD;
&#xD;
          -  Be in good general health, as determined by the Investigator/designee based on a&#xD;
             review of the health history/update for participation in the study;&#xD;
&#xD;
          -  Agree to refrain from all oral hygiene after 11 p.m. the night prior to each visit;&#xD;
&#xD;
          -  Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours&#xD;
             prior to each visit;&#xD;
&#xD;
          -  Have minimum 20 sampling sites with bleeding and pocket depth ≥2mm but not deeper than&#xD;
             4mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a dental prophylaxis within 2 weeks of Acclimation visit;&#xD;
&#xD;
          -  Having rampant caries, open or untreated caries, or advanced periodontitis requiring&#xD;
             prompt treatment;&#xD;
&#xD;
          -  A medical condition requiring an antibiotic prophylaxis prior to dental visits;&#xD;
&#xD;
          -  A history of hypersensitivity to oral care products containing stannous fluoride; or&#xD;
&#xD;
          -  Have any condition or disease, as determined by the Investigator/Designee based on a&#xD;
             review of the medical history, which could be expected to interfere with examination&#xD;
             procedures or with the subject's safe completion of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeff Milleman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Salus Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Salus Research</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>November 1, 2017</last_update_submitted>
  <last_update_submitted_qc>November 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Tin Fluorides</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/NCT03296657
org study id: CSD2017123
nct id: NCT03296657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The amount of stannous fluoride in GCF and subgingival plaque samples will be analyzed.
This is pilot study involving approximately 20 subjects with at least 20 dental pockets
      between 2- 4mm with bleeding for sampling. Subjects will have up to 10 sites identified as
      "sampling sites" that will have supragingival plaque, subgingival plaque, and gingival
      crevicular fluid (GCF) collected at Baseline, 30 minutes, 24 hours, and Week 2.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: subject will brush twice a day for 2 weeks with stannous fluoride paste for at least 1 minute
primary purpose: Basic Science
masking: None (Open Label)
measure: Amount of tin in GCF sample
time frame: mean difference from 30 minutes to baseline
description: per GCF sample amount of stannous level in ng/uL will be measured
measure: Amount of tin in GCF and Subgingival Plaque
time frame: change from visit (change from 24 hours to baseline, change Week 2 to baseline)
description: stannous level in subgingival plaque will be measured as concentration in ng, per GCF sample amount of stannous level in ng/uL
arm group label: stannous fluoride toothpaste
arm group type: Experimental
description: 0.454% stannous fluoride will be used twice a day, brushing for at least 1 minute for 2 weeks
intervention type: Drug
intervention name: stannous fluoride
description: subjects will brush with paste twice daily for 2 weeks
arm group label: stannous fluoride toothpaste
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeff Milleman
role: Principal Investigator
affiliation: Salus Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fluorides
mesh term: Tin Fluorides