<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/NCT03818945</url>
  </required_header>
  <id_info>
    <org_study_id>Nourane Yasser</org_study_id>
    <nct_id>NCT03818945</nct_id>
  </id_info>
  <brief_title>the Efficacy of Giomer Versus Sodium Fluoride in the Treatment of Hypersensitivity</brief_title>
  <official_title>Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail</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>
      to solve the problem of hypersensitivity, I will use two different materials ( Giomer versus&#xD;
      Sodium Fluoride) and compare between their effects in reliving the symptoms&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The dentin hypersensitivity is characterized by short, sharp pain which can be detected by&#xD;
      several methods. The problem is very annoying for the patients and making them seek for&#xD;
      effective rapid treatment.&#xD;
&#xD;
      It can affect several teeth in one area of the mouth or only one specific tooth. Careful&#xD;
      diagnosis of such condition necessitates precise differentiation of its signs and symptoms&#xD;
      from the other causes of tooth sensitivity which may be resulted from dental caries, micro&#xD;
      leakage, cracked tooth or fractured restoration. There are two well-known ways to reduce the&#xD;
      discomfort of the hypersensitivity either by blocking the exposed dentinal tubules by&#xD;
      occluding materials or use some depolarizing agents that reducing the excitability of the&#xD;
      intra dental nerves.Most of the desensitizing agents reduces the dentin hypersensitivity by&#xD;
      its own way and each one has different long lasting effect. But there are some drawbacks that&#xD;
      appeared with their use. Fluoride based agents were appeared in 90's but it was clarified&#xD;
      that their high concentration irritated the odontoblasts. Furthermore, the oxalates and&#xD;
      potassium nitrate were introduced to treat the hypersensitivity effectively but their effects&#xD;
      did not persist for a long period of time.&#xD;
&#xD;
      Sodium fluoride varnish is one from the most commonly used desensitizing agent and its&#xD;
      efficacy was approved in many studies. The Giomer varnish containing surface pre-reactive&#xD;
      glass particles (S-PRG) is a light-cured protective varnish and it was introduced to promote&#xD;
      prolonged protection for the hypersensitive dentin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>relieving of hypersensitivity</measure>
    <time_frame>one month</time_frame>
    <description>The sensitive teeth will be assessed by two stimuli: tactile and thermal stimuli than scored according to the visual analog scale from zero to ten.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Tooth Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>Sodium Fluoride Varnish</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PRG barrier Giomer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>shofu PRG barrier coat</intervention_name>
    <description>Trilaminar structure which forms a type of stable glass ionomer allowing ion release and recharge, while protecting the glass core from the damaging effects of moisture, greatly improving long-term durability.(Na, BO3, Al, SiO3, F,Sr)</description>
    <arm_group_label>PRG barrier Giomer</arm_group_label>
    <other_name>Light cured giomer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium fluoride varnish</intervention_name>
    <description>5% sodium fluoride [22,600 ppm F-]</description>
    <arm_group_label>Sodium Fluoride Varnish</arm_group_label>
    <other_name>Biofluoride 5% Fluoride varnish single use dose - Vocoo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 18 to 40 years.&#xD;
&#xD;
          -  No gender restriction.&#xD;
&#xD;
          -  Patients should have pain score in the visual analog scale two or more.&#xD;
&#xD;
          -  Patients must have at least one sensitive tooth in one of four quadrants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active carious lesions.&#xD;
&#xD;
          -  Needing restorative treatment.&#xD;
&#xD;
          -  Receiving periodontal treatment.&#xD;
&#xD;
          -  Taking desensitizing treatment in the last 6 months.&#xD;
&#xD;
          -  Taking anti-inflammatory drugs.&#xD;
&#xD;
          -  Pregnant patients.&#xD;
&#xD;
          -  Smokers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nourane Yassin, Bachelor</last_name>
      <phone>01006889918</phone>
      <email>Nourane090248@miuegypt.edu.eg</email>
    </contact>
    <contact_backup>
      <last_name>Aya Nemtallah, Master Degree</last_name>
      <phone>01006682419</phone>
      <email>aya.mohammed@dentistry.cu.edu.eg</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nourane Yasser Ali</investigator_full_name>
    <investigator_title>Principal investigator in Cairo university</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/NCT03818945
org study id: Nourane Yasser
nct id: NCT03818945
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
to solve the problem of hypersensitivity, I will use two different materials ( Giomer versus
      Sodium Fluoride) and compare between their effects in reliving the symptoms
The dentin hypersensitivity is characterized by short, sharp pain which can be detected by
      several methods. The problem is very annoying for the patients and making them seek for
      effective rapid treatment.

      It can affect several teeth in one area of the mouth or only one specific tooth. Careful
      diagnosis of such condition necessitates precise differentiation of its signs and symptoms
      from the other causes of tooth sensitivity which may be resulted from dental caries, micro
      leakage, cracked tooth or fractured restoration. There are two well-known ways to reduce the
      discomfort of the hypersensitivity either by blocking the exposed dentinal tubules by
      occluding materials or use some depolarizing agents that reducing the excitability of the
      intra dental nerves.Most of the desensitizing agents reduces the dentin hypersensitivity by
      its own way and each one has different long lasting effect. But there are some drawbacks that
      appeared with their use. Fluoride based agents were appeared in 90's but it was clarified
      that their high concentration irritated the odontoblasts. Furthermore, the oxalates and
      potassium nitrate were introduced to treat the hypersensitivity effectively but their effects
      did not persist for a long period of time.

      Sodium fluoride varnish is one from the most commonly used desensitizing agent and its
      efficacy was approved in many studies. The Giomer varnish containing surface pre-reactive
      glass particles (S-PRG) is a light-cured protective varnish and it was introduced to promote
      prolonged protection for the hypersensitive dentin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: relieving of hypersensitivity
time frame: one month
description: The sensitive teeth will be assessed by two stimuli: tactile and thermal stimuli than scored according to the visual analog scale from zero to ten.
arm group label: Sodium Fluoride Varnish
arm group type: Other
arm group label: PRG barrier Giomer
arm group type: Active Comparator
intervention type: Drug
intervention name: shofu PRG barrier coat
description: Trilaminar structure which forms a type of stable glass ionomer allowing ion release and recharge, while protecting the glass core from the damaging effects of moisture, greatly improving long-term durability.(Na, BO3, Al, SiO3, F,Sr)
arm group label: PRG barrier Giomer
other name: Light cured giomer
intervention type: Drug
intervention name: Sodium fluoride varnish
description: 5% sodium fluoride [22,600 ppm F-]
arm group label: Sodium Fluoride Varnish
other name: Biofluoride 5% Fluoride varnish single use dose - Vocoo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nourane Yasser Ali
investigator title: Principal investigator in Cairo university
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride
mesh term: Fluorides, Topical