<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/NCT03027908</url>
  </required_header>
  <id_info>
    <org_study_id>ORL-GUM-2544</org_study_id>
    <nct_id>NCT03027908</nct_id>
  </id_info>
  <brief_title>A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period</brief_title>
  <official_title>A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unilever R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240&#xD;
      healthy female and male participants aged over 18 years will participate. The participants&#xD;
      will be randomised into two groups. Participants will be randomly assigned to the test groups&#xD;
      according the allocation table prepared by the Statistician.&#xD;
&#xD;
      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.&#xD;
      After enrollment participants will have their teeth cleaned using a professional prophylaxis&#xD;
      polish by the study hygienist. The participants will then be provided with a standard&#xD;
      cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to&#xD;
      four weeks. After this time, they will return to the test site and have the baseline dental&#xD;
      assessments. Participants will then be randomly allocated to one of the two test products&#xD;
      which they will use at home, twice a day for the duration of the study. Dental assessments&#xD;
      will be conducted after 13 and 26 weeks of product use at the study site.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2016</start_date>
  <completion_date type="Actual">May 8, 2017</completion_date>
  <primary_completion_date type="Actual">May 8, 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gingival condition as measured by the Modified Lobene Gingival Index</measure>
    <time_frame>13 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index</measure>
    <time_frame>13 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plaque levels as measure by the Quigley and Hein Plaque index</measure>
    <time_frame>13 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in gingival condition as measured by the Modified Lobene Gingival Index</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in gingival condition as measured by the Saxton van der Ouderaa bleeding index</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plaque levels as measured by the Quigley and Hein plaque index</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">239</enrollment>
  <condition>Gingival Diseases</condition>
  <arm_group>
    <arm_group_label>Fluoride Toothpaste 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Toothpaste containing Sodium Fluoride at 1450 ppm F</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoride Toothpaste 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Toothpaste containing Sodium Fluoride at 1450 ppm F</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluoride Toothpaste 1</intervention_name>
    <description>Toothpaste containing 1450 ppm F as Sodium Fluoride</description>
    <arm_group_label>Fluoride Toothpaste 1</arm_group_label>
    <other_name>A1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluoride Toothpaste 2</intervention_name>
    <description>Toothpaste containing 1450 ppm F as Sodium Fluoride</description>
    <arm_group_label>Fluoride Toothpaste 2</arm_group_label>
    <other_name>A2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be willing and physically able to carry out all study procedures.&#xD;
&#xD;
          -  Be willing and competent (verbally and cognitively) to give written informed consent&#xD;
             and complete a medical history form.&#xD;
&#xD;
          -  Have at least 20 natural teeth including 5 teeth (excluding 3rd molars) in each&#xD;
             quadrant&#xD;
&#xD;
          -  Have a mean Modified Gingival Index (MGI) score of between 2.00 and 2.75 at screening.&#xD;
&#xD;
          -  Not have had a scale and prophylaxis in the month prior to enrolment or have one&#xD;
             scheduled prior to the end of the study.&#xD;
&#xD;
          -  Be willing to use only the test products for 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current participation in any other cosmetic trials, any dental clinical trials or&#xD;
             clinical trials.&#xD;
&#xD;
          -  Pregnant or breast feeding mothers.&#xD;
&#xD;
          -  Medical condition and/or regular use of any medication which might affect the outcome&#xD;
             of the study, as determined by the study dentist, principally a course of&#xD;
             anti-inflammatory, antimicrobial or statin drugs&#xD;
&#xD;
          -  Obvious signs of untreated caries or significant periodontal disease, which in the&#xD;
             opinion of the Study Dentist, will affect either the scientific validity of the study&#xD;
             or if the participant was to participate in the study would affect their wellbeing.&#xD;
&#xD;
          -  Any participant who, in the judgement of the investigator, should not participate in&#xD;
             the study.&#xD;
&#xD;
          -  Full or partial dentures wearers.&#xD;
&#xD;
          -  Current orthodontic treatment.&#xD;
&#xD;
          -  Have oral piercings.&#xD;
&#xD;
          -  Smokers or those who have a recent smoking history, including e-cigarettes.&#xD;
&#xD;
          -  Taking dietary supplements (e.g. multivitamins; antioxidants; fish oils).&#xD;
&#xD;
          -  Any subject with a single MGI score of 4 in the any area of the mouth at any time&#xD;
             point will be excluded.&#xD;
&#xD;
          -  A subject will be excluded from the study if they have a MGI mouth mean of greater&#xD;
             than 2.75 at screening&#xD;
&#xD;
          -  Any subject with a single MGI score of 3 at Baseline&#xD;
&#xD;
          -  Use of non study oral care products, e.g. dental floss, chewing gum, mouth rinses&#xD;
             during the pre treatment and test phases of the study.&#xD;
&#xD;
          -  The subject is an employee of Unilever or a member of the study team.&#xD;
&#xD;
          -  Taking a course of antimicrobial or anti-inflammatory drugs within 4 weeks of&#xD;
             screening&#xD;
&#xD;
          -  Those taking anti-histamine or anti-inflammatory medication in the 24 hours prior to&#xD;
             the dental assessments&#xD;
&#xD;
          -  Diabetics&#xD;
&#xD;
          -  Vegetarians and Vegans&#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>Nicola X West, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bristol</affiliation>
  </overall_official>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</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/NCT03027908
org study id: ORL-GUM-2544
nct id: NCT03027908
lead sponsor: 
has dmc: No
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240
      healthy female and male participants aged over 18 years will participate. The participants
      will be randomised into two groups. Participants will be randomly assigned to the test groups
      according the allocation table prepared by the Statistician.

      Participants will be enrolled on to the study according to the inclusion/exclusion criteria.
      After enrollment participants will have their teeth cleaned using a professional prophylaxis
      polish by the study hygienist. The participants will then be provided with a standard
      cosmetic silica fluoride toothpaste and a toothbrush to use at home, twice a day for up to
      four weeks. After this time, they will return to the test site and have the baseline dental
      assessments. Participants will then be randomly allocated to one of the two test products
      which they will use at home, twice a day for the duration of the study. Dental assessments
      will be conducted after 13 and 26 weeks of product use at the study site.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in gingival condition as measured by the Modified Lobene Gingival Index
time frame: 13 weeks
measure: Change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
time frame: 13 weeks
measure: Change in plaque levels as measure by the Quigley and Hein Plaque index
time frame: 13 weeks
measure: change in gingival condition as measured by the Modified Lobene Gingival Index
time frame: 26 weeks
measure: change in gingival condition as measured by the Saxton van der Ouderaa bleeding index
time frame: 26 weeks
measure: Change in plaque levels as measured by the Quigley and Hein plaque index
time frame: 26 weeks
arm group label: Fluoride Toothpaste 1
arm group type: Experimental
description: Toothpaste containing Sodium Fluoride at 1450 ppm F
arm group label: Fluoride Toothpaste 2
arm group type: Active Comparator
description: Toothpaste containing Sodium Fluoride at 1450 ppm F
intervention type: Other
intervention name: Fluoride Toothpaste 1
description: Toothpaste containing 1450 ppm F as Sodium Fluoride
arm group label: Fluoride Toothpaste 1
other name: A1
intervention type: Other
intervention name: Fluoride Toothpaste 2
description: Toothpaste containing 1450 ppm F as Sodium Fluoride
arm group label: Fluoride Toothpaste 2
other name: A2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicola X West, Professor
role: Principal Investigator
affiliation: University of Bristol
responsible party type: Sponsor
mesh term: Gingival Diseases
mesh term: Fluorides
sharing ipd: No