<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/NCT04485299</url>
  </required_header>
  <id_info>
    <org_study_id>OPR 20/7/2020</org_study_id>
    <nct_id>NCT04485299</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient</brief_title>
  <official_title>Quantitative Clinical Assessment of Bifluorid 10 Versus Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient: 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>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus&#xD;
      conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of&#xD;
      exposed cervical area in adult patients over 2 month&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dentin hypersensitivity</measure>
    <time_frame>pre-intervention</time_frame>
    <description>measurement of dentin hypersensitivity by VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dentin hypersensitivity</measure>
    <time_frame>2 min</time_frame>
    <description>measurement of dentin hypersensitivity by VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dentin hypersensitivity</measure>
    <time_frame>1 week</time_frame>
    <description>measurement of dentin hypersensitivity by VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dentin hypersensitivity</measure>
    <time_frame>4 weeks</time_frame>
    <description>measurement of dentin hypersensitivity by VAS scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dentin hypersensitivity</measure>
    <time_frame>8 weeks</time_frame>
    <description>measurement of dentin hypersensitivity by VAS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dentinal tubule occlusion</measure>
    <time_frame>Pre-intervention</time_frame>
    <description>Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dentinal tubule occlusion</measure>
    <time_frame>8 weeks</time_frame>
    <description>Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Hypersensitivity</condition>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>bifluorid 10 varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sodium fluoride varnish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bifluorid 10 ,VOCO</intervention_name>
    <description>NaF and CaF 10 %</description>
    <arm_group_label>bifluorid 10 varnish</arm_group_label>
    <other_name>Bifluorid 10</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Fluoride 5% Dental Varnish</intervention_name>
    <description>5% NaF</description>
    <arm_group_label>sodium fluoride varnish</arm_group_label>
    <other_name>conventional sodium fluoride varnish</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy patient with free medical history.&#xD;
&#xD;
          -  Age range 18-60 years old.&#xD;
&#xD;
          -  Good oral hygiene&#xD;
&#xD;
          -  Patients suffering from pain due to dentin hypersensitivity.&#xD;
&#xD;
          -  Patient with sound first molar .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients using desensitizing agents, receiving periodontal treatment or had received&#xD;
             nonsurgical periodontal treatment in the last three months.&#xD;
&#xD;
          -  Patient wearing orthodontic appliance.&#xD;
&#xD;
          -  Patient with teeth having a painful condition involving the pulp and periapical&#xD;
             region.&#xD;
&#xD;
          -  Patients who had allergy to materials will be used in the study.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patient who does not consent to participation.&#xD;
&#xD;
          -  Patient who does not attend to the follow up.&#xD;
&#xD;
          -  A patient who has a carious first molar.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zaid Yousef Alkhatteb, BSc</last_name>
    <phone>00201272111897</phone>
    <email>zaid_yousef@denstistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Zaid Yousef Fakhry Al khateeb</investigator_full_name>
    <investigator_title>Master's degree student - faculty of dentistry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</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>
    <mesh_term>Fluorides, Topical</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/NCT04485299
org study id: OPR 20/7/2020
nct id: NCT04485299
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Aim of the study will be conducted to compare the efficacy of bifluoride (NaF and CaF) versus
      conventional fluoride varnish (Sodium Flouride) in the management of hypersensitivity of
      exposed cervical area in adult patients over 2 month
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Dentin hypersensitivity
time frame: pre-intervention
description: measurement of dentin hypersensitivity by VAS scale
measure: Dentin hypersensitivity
time frame: 2 min
description: measurement of dentin hypersensitivity by VAS scale
measure: Dentin hypersensitivity
time frame: 1 week
description: measurement of dentin hypersensitivity by VAS scale
measure: Dentin hypersensitivity
time frame: 4 weeks
description: measurement of dentin hypersensitivity by VAS scale
measure: Dentin hypersensitivity
time frame: 8 weeks
description: measurement of dentin hypersensitivity by VAS scale
measure: Dentinal tubule occlusion
time frame: Pre-intervention
description: Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
measure: Dentinal tubule occlusion
time frame: 8 weeks
description: Percentage of dentinal tubule occlusion measure by scanning electron microscope SEM
arm group label: bifluorid 10 varnish
arm group type: Experimental
description: Bifluorid 10 (NaF and CaF) lead to reduce the dentin hypersensitivity, the sodium fluoride (NaF) dissociates and releases F ions, that diffuse through the tubules and then precipitates as calcium fluoride as a consequence of the high of calcium content in saliva and dentinal fluid ,The calcium fluoride (CaF) present in the varnish composition diffuses into the tubules and block the canal with a semi-permanent protective layer.The calcium fluoride is added to block the dentin tubules mechanically, by the combination with the calcium fluoride resulted from the sodium fluoride reaction to the calcium of dentin.
arm group label: sodium fluoride varnish
arm group type: Active Comparator
description: Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent, the varnish fluoride process is caused by the reaction between NaF and calcium ions resulting in calcium fluoride crystals being deposited on the openings of the dentinal tubules that decrease pain.
intervention type: Drug
intervention name: Bifluorid 10 ,VOCO
description: NaF and CaF 10 %
arm group label: bifluorid 10 varnish
other name: Bifluorid 10
intervention type: Drug
intervention name: Sodium Fluoride 5% Dental Varnish
description: 5% NaF
arm group label: sodium fluoride varnish
other name: conventional sodium fluoride varnish
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zaid Yousef Alkhatteb, BSc
phone: 00201272111897
email: zaid_yousef@denstistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Zaid Yousef Fakhry Al khateeb
investigator title: Master's degree student - faculty of dentistry
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
mesh term: Fluorides, Topical