<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/NCT04472182</url>
  </required_header>
  <id_info>
    <org_study_id>CairoUniv</org_study_id>
    <nct_id>NCT04472182</nct_id>
  </id_info>
  <brief_title>Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients</brief_title>
  <official_title>Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial will be conducted to compare the efficacy of fluoride varnish containing&#xD;
      xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride&#xD;
      varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult&#xD;
      patients over a 12 months period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2020</start_date>
  <completion_date type="Actual">December 21, 2021</completion_date>
  <primary_completion_date type="Actual">December 21, 2021</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Dentin Hypersensitivity</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain due to Dentin Hypersensitivity</measure>
    <time_frame>Two minutes before intervention</time_frame>
    <description>Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to Dentin Hypersensitivity</measure>
    <time_frame>4 hours</time_frame>
    <description>Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to Dentin Hypersensitivity</measure>
    <time_frame>2 days</time_frame>
    <description>Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to Dentin Hypersensitivity</measure>
    <time_frame>4 months</time_frame>
    <description>Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to Dentin Hypersensitivity</measure>
    <time_frame>8 months</time_frame>
    <description>Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain due to Dentin Hypersensitivity</measure>
    <time_frame>12 months</time_frame>
    <description>Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measuring Salivary pH</measure>
    <time_frame>Two minutes before intervention</time_frame>
    <description>measuring Unstimulated Salivary pH using pH meter from 0-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Salivary pH</measure>
    <time_frame>4 hours</time_frame>
    <description>measuring Unstimulated Salivary pH using pH meter from 0-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Salivary pH</measure>
    <time_frame>2 days</time_frame>
    <description>measuring Unstimulated Salivary pH using pH meter from 0-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Salivary pH</measure>
    <time_frame>4 months</time_frame>
    <description>measuring Unstimulated Salivary pH using pH meter from 0-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Salivary pH</measure>
    <time_frame>8 months</time_frame>
    <description>measuring Unstimulated Salivary pH using pH meter from 0-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Salivary pH</measure>
    <time_frame>12 months</time_frame>
    <description>measuring Unstimulated Salivary pH using pH meter from 0-14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image analysis to assess amount of plaque adherence</measure>
    <time_frame>2 minutes before intervention</time_frame>
    <description>Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image analysis to assess amount of plaque adherence</measure>
    <time_frame>4 hours</time_frame>
    <description>Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image analysis to assess amount of plaque adherence</measure>
    <time_frame>2 days</time_frame>
    <description>Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image analysis to assess amount of plaque adherence</measure>
    <time_frame>4 months</time_frame>
    <description>Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image analysis to assess amount of plaque adherence</measure>
    <time_frame>8 months</time_frame>
    <description>Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Image analysis to assess amount of plaque adherence</measure>
    <time_frame>12 months</time_frame>
    <description>Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>Fluoride varnish with xylitol coated calcium and phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Fluoride varnish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoride varnish with xylitol coated calcium and phosphate</intervention_name>
    <description>Fluoride varnish with xylitol coated calcium and phosphate</description>
    <arm_group_label>Conventional Fluoride varnish</arm_group_label>
    <arm_group_label>Fluoride varnish with xylitol coated calcium and phosphate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria of participants:&#xD;
&#xD;
        Males or females. Age: 20-50 years old. Patients having at least one tooth with exposed&#xD;
        root surface Teeth with hypersensitivity, VAS ≥5 Patients with good oral hygiene.&#xD;
        Co-operative patients who show interest to participate in the study&#xD;
&#xD;
        Exclusion criteria of participants:&#xD;
&#xD;
        Patients with bad oral hygiene Patients with orthodontic appliances, or bridge work that&#xD;
        might interfere with evaluation Patients who are allergic to any ingredients will be used&#xD;
        in the study. Carious teeth Mobile teeth. (Grade 2 or Grade 3) Teeth with hypersensitivity,&#xD;
        VAS &lt;5 Patients with physical disabilities Pregnant or lactating women Other dental defects&#xD;
        that causes pain. Allergy from any used materials or any allergic reaction during our&#xD;
        clinical trial (The trial will be stopped at once and all the needed management against any&#xD;
        allergic reaction will be done.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter E Abdelmalik, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo U</name>
      <address>
        <city>Giza</city>
        <zip>12311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 11, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>January 20, 2022</last_update_submitted>
  <last_update_submitted_qc>January 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Peter Edward Ibrahim Abdelmalik</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04472182
org study id: CairoUniv
nct id: NCT04472182
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical trial will be conducted to compare the efficacy of fluoride varnish containing
      xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride
      varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult
      patients over a 12 months period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Dentin Hypersensitivity
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pain due to Dentin Hypersensitivity
time frame: Two minutes before intervention
description: Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
measure: Pain due to Dentin Hypersensitivity
time frame: 4 hours
description: Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
measure: Pain due to Dentin Hypersensitivity
time frame: 2 days
description: Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
measure: Pain due to Dentin Hypersensitivity
time frame: 4 months
description: Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
measure: Pain due to Dentin Hypersensitivity
time frame: 8 months
description: Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
measure: Pain due to Dentin Hypersensitivity
time frame: 12 months
description: Pain arising from Dentin Hypersensitivity on exposed root surfaces using air blast measured by 10 cm VAS scale
measure: Measuring Salivary pH
time frame: Two minutes before intervention
description: measuring Unstimulated Salivary pH using pH meter from 0-14
measure: Measuring Salivary pH
time frame: 4 hours
description: measuring Unstimulated Salivary pH using pH meter from 0-14
measure: Measuring Salivary pH
time frame: 2 days
description: measuring Unstimulated Salivary pH using pH meter from 0-14
measure: Measuring Salivary pH
time frame: 4 months
description: measuring Unstimulated Salivary pH using pH meter from 0-14
measure: Measuring Salivary pH
time frame: 8 months
description: measuring Unstimulated Salivary pH using pH meter from 0-14
measure: Measuring Salivary pH
time frame: 12 months
description: measuring Unstimulated Salivary pH using pH meter from 0-14
measure: Image analysis to assess amount of plaque adherence
time frame: 2 minutes before intervention
description: Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
measure: Image analysis to assess amount of plaque adherence
time frame: 4 hours
description: Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
measure: Image analysis to assess amount of plaque adherence
time frame: 2 days
description: Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
measure: Image analysis to assess amount of plaque adherence
time frame: 4 months
description: Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
measure: Image analysis to assess amount of plaque adherence
time frame: 8 months
description: Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
measure: Image analysis to assess amount of plaque adherence
time frame: 12 months
description: Calculating the percentage (0%-100%) of area with plaque adherence in relation to the total area of the tooth surface
arm group label: Fluoride varnish with xylitol coated calcium and phosphate
arm group type: Experimental
arm group label: Conventional Fluoride varnish
arm group type: Active Comparator
intervention type: Drug
intervention name: Fluoride varnish with xylitol coated calcium and phosphate
description: Fluoride varnish with xylitol coated calcium and phosphate
arm group label: Conventional Fluoride varnish
arm group label: Fluoride varnish with xylitol coated calcium and phosphate
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter E Abdelmalik, Master
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Peter Edward Ibrahim Abdelmalik
investigator title: Assistant Lecturer
mesh term: Hypersensitivity
mesh term: Calcium
mesh term: Fluorides
mesh term: Fluorides, Topical
sharing ipd: Undecided