<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/NCT04484844</url>
  </required_header>
  <id_info>
    <org_study_id>OPER 20/7/2020</org_study_id>
    <nct_id>NCT04484844</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity</brief_title>
  <official_title>Clinical Evaluation of Efficacy of Shield Force Plus Varnish Versus Sodium Fluoride on Cervical Dentin Hypersensitivity on 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>
    <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>
      The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus&#xD;
      sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult&#xD;
      patients for 8weeks.&#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>Dentin Hypersensitivity</condition>
  <condition>Dentin Desensitizing Agents</condition>
  <arm_group>
    <arm_group_label>Shield Force Plus Varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shield force plus (SFP), Self-reinforcing (SR) monomer technology supplied in the form of one component self-etching light-cured dental adhesive, which is characterized by an SR monomer component that penetrates the tooth substrate. Multi-point interactions with apatite calcium and three-dimensional cross-linking occur reactions.it forms a thin even, hard coating on the tooth surface that gives the tooth substrate a superior binding power.</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>TOKUYAMA SHIELD FORCE PLUS</intervention_name>
    <description>Self-reinforcing (SR) monomer technology</description>
    <arm_group_label>Shield Force Plus Varnish</arm_group_label>
  </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>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with good oral hygiene.&#xD;
&#xD;
          -  The age range of 18-65 years.&#xD;
&#xD;
          -  Patients from both gender.&#xD;
&#xD;
          -  Patients suffering from pain due to dentin hypersensitivity.&#xD;
&#xD;
          -  Patients with sound first upper molars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with teeth exhibiting mobility (grade 2 or 3).&#xD;
&#xD;
          -  Patients with constant use of analgesic, carious lesions, fractured teeth, defective&#xD;
             restorations or prosthesis.&#xD;
&#xD;
          -  Patients with orthodontics appliance.&#xD;
&#xD;
          -  Patients with allergy sufferers with any of the materials will be used in the study as&#xD;
             shield force plus and sodium fluoride.&#xD;
&#xD;
          -  Patients with carious, crowned upper first molars.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Feras Mustafa Salem, BSc</last_name>
    <phone>00201008471183</phone>
    <email>feras.fares@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 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>Feras Mustafa Fares Salem</investigator_full_name>
    <investigator_title>Master's degree student - faculty of dentistry</investigator_title>
  </responsible_party>
  <keyword>Dentin hypersensitivity</keyword>
  <keyword>Dentin sensitivity</keyword>
  <keyword>Shield force plus</keyword>
  <keyword>Dentin Desensitizing Agents</keyword>
  <keyword>sodium fluoride varnish</keyword>
  <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>
  </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/NCT04484844
org study id: OPER 20/7/2020
nct id: NCT04484844
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The aim of the study to compare the clinical effectiveness of Shield Force Plus (SFP) versus
      sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult
      patients for 8weeks.
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: Shield Force Plus Varnish
arm group type: Experimental
description: Shield force plus (SFP), Self-reinforcing (SR) monomer technology supplied in the form of one component self-etching light-cured dental adhesive, which is characterized by an SR monomer component that penetrates the tooth substrate. Multi-point interactions with apatite calcium and three-dimensional cross-linking occur reactions.it forms a thin even, hard coating on the tooth surface that gives the tooth substrate a superior binding power.
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: TOKUYAMA SHIELD FORCE PLUS
description: Self-reinforcing (SR) monomer technology
arm group label: Shield Force Plus Varnish
intervention type: Drug
intervention name: Sodium Fluoride 5% Dental Varnish
description: 5% NaF
arm group label: Sodium Fluoride varnish
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Feras Mustafa Salem, BSc
phone: 00201008471183
email: feras.fares@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Feras Mustafa Fares Salem
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