<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/NCT02971514</url>
  </required_header>
  <id_info>
    <org_study_id>920200</org_study_id>
    <nct_id>NCT02971514</nct_id>
  </id_info>
  <brief_title>Comparative Efficacy of Dental Flossing Before or After Tooth Brushing on Interproximal Plaque Reduction and Fluoride Retention in That Area</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled crossover trial conducted on 25 dental students. in the&#xD;
      preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and&#xD;
      toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were&#xD;
      instructed the proper techniques of brushing and flossing.The study was performed in two&#xD;
      treatment sessions and a 48 hour washout period. They passed through the sessions in a&#xD;
      randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all&#xD;
      oral hygiene for 24 hour. At the first session , they flossed first followed by brushing&#xD;
      (floss-brush group) and at the other session they used dental floss after brushing&#xD;
      (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque&#xD;
      reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was&#xD;
      collected for measuring fluoride. Differences between the two groups were analyzed with mixed&#xD;
      model test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Actual">April 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental plaque reduction</measure>
    <time_frame>immediately Before brushing/ flossing and immediately after these procedures</time_frame>
    <description>Dental plaque assessed using a scale known as: &quot;Rustogi Modified Navy Plaque Index&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>fluoride concentration in Interdental plaque</measure>
    <time_frame>Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement</time_frame>
    <description>fluoride concentration measured using ppm scale (microgram/milliliter)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Dental Devices, Home Care</condition>
  <arm_group>
    <arm_group_label>Floss-Brush group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants flossed first followed by brushing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brush-Floss group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They used dental floss after brushing</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Flossing before Brushing</intervention_name>
    <arm_group_label>Floss-Brush group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brushing before Flossing</intervention_name>
    <arm_group_label>Brush-Floss group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dental students with 16 teeth in each jaw who had Normal salivary volume No active&#xD;
             caries No medicine which could be affect salivary secretion No fluoride consumption in&#xD;
             the last two weeks No Antibiotic consumption in the last 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic diseases Periodontal diseases Crowding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amir Moeintaghavi</name>
      <address>
        <city>Mashhad</city>
        <state>Khorasan Razavi</state>
        <zip>91735-984</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 19, 2016</last_update_submitted>
  <last_update_submitted_qc>November 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Fatemeh Mazhari</investigator_full_name>
    <investigator_title>Associate professor od Pedodontics</investigator_title>
  </responsible_party>
  <!-- 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/NCT02971514
org study id: 920200
nct id: NCT02971514
lead sponsor: 
has dmc: Yes
This randomized controlled crossover trial conducted on 25 dental students. in the
      preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and
      toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were
      instructed the proper techniques of brushing and flossing.The study was performed in two
      treatment sessions and a 48 hour washout period. They passed through the sessions in a
      randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all
      oral hygiene for 24 hour. At the first session , they flossed first followed by brushing
      (floss-brush group) and at the other session they used dental floss after brushing
      (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque
      reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was
      collected for measuring fluoride. Differences between the two groups were analyzed with mixed
      model test.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Dental plaque reduction
time frame: immediately Before brushing/ flossing and immediately after these procedures
description: Dental plaque assessed using a scale known as: "Rustogi Modified Navy Plaque Index"
measure: fluoride concentration in Interdental plaque
time frame: Immediately after toothbrushing /flossing interdental plaque was collected for fluoride measurement
description: fluoride concentration measured using ppm scale (microgram/milliliter)
arm group label: Floss-Brush group
arm group type: Experimental
description: The participants flossed first followed by brushing
arm group label: Brush-Floss group
arm group type: Active Comparator
description: They used dental floss after brushing
intervention type: Behavioral
intervention name: Flossing before Brushing
arm group label: Floss-Brush group
intervention type: Behavioral
intervention name: Brushing before Flossing
arm group label: Brush-Floss group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Fatemeh Mazhari
investigator title: Associate professor od Pedodontics