xml: <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/NCT06025084</url>
    </required_header>
    <id_info>
      <org_study_id>Fadia Ali El-Sayed Shosha</org_study_id>
      <nct_id>NCT06025084</nct_id>
    </id_info>
    <brief_title>The Effect of the Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles</brief_title>
    <official_title>The Effect of Egg Shell Nanoparticles Combined With Titanium Dioxide Nanoparticles on The Permeability of Dentinal Tubules After Exposure to Wear Challenges and Their Clinical Efficacy in The Treatment of Dentin Hypersensitivity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Egymedicalpedia</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Egymedicalpedia</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions&#xD;
        which is characterized by short and sharp pain which arises from exposed dentin in response&#xD;
        to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical.&#xD;
  &#xD;
        Hypersensitive dentin is mostly found in buccal tooth areas, in which enamel is missing&#xD;
        because of abrasion, attrition, or erosion. The most generally accepted theory regarding the&#xD;
        mechanism of dentin hypersensitivity is the hydrodynamic theory. It proposes that a&#xD;
        pain-provoking stimulus increases the flow of the dentinal tubular fluid and consequently,&#xD;
        stimulates the nerves around the odontoblasts, leading to dentin hypersensitivity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dentin desensitizing products, containing agents such as fluoride, strontium salts, oxalate,&#xD;
        glutaraldehyde and bioactive glass, are employed to treat dentin hypersensitivity.&#xD;
  &#xD;
        Based on the hydrodynamic theory, there are two main strategies for the treatment of dentin&#xD;
        hypersensitivity as: (1) occluding the dentinal tubules to reduce the fluid flow, and (2)&#xD;
        decreasing the excitability of the intradental nerve.&#xD;
  &#xD;
        Although these products and agents were reported to be effective, short durability and poor&#xD;
        effectiveness were often exhibited. The therapeutic effects of these desensitizing products&#xD;
        were short lived on account of daily tooth brushing or drinking of acidic beverages and the&#xD;
        occlusion effects were sometimes incomplete. Owing to these drawbacks, the use of&#xD;
        nanomaterials as dentin occluding material has been predicted to be the future of treating&#xD;
        DH.&#xD;
  &#xD;
        Amorphous Calcium Phosphate (ACP) has the potential to remineralize the structure of tooth.&#xD;
        ACP is a soluble calcium phosphate compound that discharges calcium and phosphate ions to&#xD;
        change to apatite and remineralize the tooth structure when it comes in contact with saliva.&#xD;
        Forming on the enamel and within the dental tubules, ACP provides a reservoir of phosphate&#xD;
        and calcium ions in the saliva Casein phospho-peptide (CPP) is a milk-derived protein that&#xD;
        joins to the tooth's biofilm and is applied to stabilize ACP. In recent years,&#xD;
        remineralization products used CPP as a vehicle to deliver and preserve a super saturation&#xD;
        state of ACP near the surface of tooth. A previous study showed that the application of&#xD;
        (CPP-ACP) containing agents as GC tooth mousse and MI paste plus can reduce dentin&#xD;
        permeability by occluding dentin tubules. It revealed that these materials can be effective&#xD;
        for treatment of dentin hypersensitivity.&#xD;
  &#xD;
        Recently, there has been a renewed interest in developing materials with a bioactive&#xD;
        potential that could block the exposed dentinal tubules and subsequently reduce the fluid&#xD;
        flow within the tubules. Eggshells (EBs) have been investigated in recent years for their&#xD;
        remineralization capabilities. EB has rich bioavailable calcium content in the form of&#xD;
        carbonates and oxides. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium&#xD;
        carbonate, and 4% organic matter. In addition, eggshell provides a cost-effective, renewable,&#xD;
        and sustainable source of material for EnHAp. A previous study revealed that eggshell powder&#xD;
        is predicted to be the future of tooth remineralization and highly effective in occluding&#xD;
        dentinal tubules and reducing dentin hypersensitivity.&#xD;
  &#xD;
        Titanium dioxide is one of the few materials that classified as bioactive meaning that it&#xD;
        enhances bone growth and stable bone bonding with dental implants via precipitation of&#xD;
        hydroxyapatite on its surface&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Actual">March 30, 2023</completion_date>
    <primary_completion_date type="Actual">March 15, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of dentin hypersensitivity</measure>
      <time_frame>from baseline to 2 months after the treatment day.</time_frame>
      <description>The pain response will be assessed using the numerical Visual Analogue Scale (VAS, range 0-10), with 0 indicating 'no pain' and 10 indicating 'intolerably severe pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Dentin Hypersensitivity</condition>
    <arm_group>
      <arm_group_label>first group (A1)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles</description>
    </arm_group>
    <arm_group>
      <arm_group_label>second group (A2)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Egg Shell nanoparticles</intervention_name>
      <description>Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.</description>
      <arm_group_label>first group (A1)</arm_group_label>
      <arm_group_label>second group (A2)</arm_group_label>
      <other_name>Titanium dioxide nanoparticles</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1- For patients;&#xD;
  &#xD;
            -  Age between 20 and 55 years&#xD;
  &#xD;
            -  Patients in good systemic health with clinically elicitable dentin hypersensitivity&#xD;
  &#xD;
            -  Absence of contraindications to the proposed therapies as allergy. 2 - For teeth;&#xD;
  &#xD;
            -  Absence of local pathologies (e.g., caries and fractures)&#xD;
  &#xD;
            -  Visual analog scale (VAS) score ≥3&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  -- For patients;&#xD;
  &#xD;
                 -  Use of any desensitizing toothpaste for previous 3 or 4 months.&#xD;
  &#xD;
                 -  Taking analgesics/anti-inflammatory drugs at the time of the study, pregnancy,&#xD;
                    and smoking.&#xD;
  &#xD;
                    2 -For teeth ;&#xD;
  &#xD;
                 -  Teeth with abrasion and attrition.&#xD;
  &#xD;
                 -  Carious lesions on the selected or neighboring teeth, defective restorations&#xD;
  &#xD;
                 -  Any professional desensitizing therapy on the selected teeth during the last 6&#xD;
                    months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatma Hussein, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Al-Azhar Faculty of Dentistary for girls</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Dentistary - Al-Azhar University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>Titanium dioxide</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025084
  org study id: Fadia Ali El-Sayed Shosha
  nct id: NCT06025084
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dentin hypersensitivity is one of the most commonly occurring clinical dental conditions
        which is characterized by short and sharp pain which arises from exposed dentin in response
        to external stimuli, which typically are thermal, evaporative, tactile, osmotic or chemical.
  
        Hypersensitive dentin is mostly found in buccal tooth areas, in which enamel is missing
        because of abrasion, attrition, or erosion. The most generally accepted theory regarding the
        mechanism of dentin hypersensitivity is the hydrodynamic theory. It proposes that a
        pain-provoking stimulus increases the flow of the dentinal tubular fluid and consequently,
        stimulates the nerves around the odontoblasts, leading to dentin hypersensitivity.
  Dentin desensitizing products, containing agents such as fluoride, strontium salts, oxalate,
        glutaraldehyde and bioactive glass, are employed to treat dentin hypersensitivity.
  
        Based on the hydrodynamic theory, there are two main strategies for the treatment of dentin
        hypersensitivity as: (1) occluding the dentinal tubules to reduce the fluid flow, and (2)
        decreasing the excitability of the intradental nerve.
  
        Although these products and agents were reported to be effective, short durability and poor
        effectiveness were often exhibited. The therapeutic effects of these desensitizing products
        were short lived on account of daily tooth brushing or drinking of acidic beverages and the
        occlusion effects were sometimes incomplete. Owing to these drawbacks, the use of
        nanomaterials as dentin occluding material has been predicted to be the future of treating
        DH.
  
        Amorphous Calcium Phosphate (ACP) has the potential to remineralize the structure of tooth.
        ACP is a soluble calcium phosphate compound that discharges calcium and phosphate ions to
        change to apatite and remineralize the tooth structure when it comes in contact with saliva.
        Forming on the enamel and within the dental tubules, ACP provides a reservoir of phosphate
        and calcium ions in the saliva Casein phospho-peptide (CPP) is a milk-derived protein that
        joins to the tooth's biofilm and is applied to stabilize ACP. In recent years,
        remineralization products used CPP as a vehicle to deliver and preserve a super saturation
        state of ACP near the surface of tooth. A previous study showed that the application of
        (CPP-ACP) containing agents as GC tooth mousse and MI paste plus can reduce dentin
        permeability by occluding dentin tubules. It revealed that these materials can be effective
        for treatment of dentin hypersensitivity.
  
        Recently, there has been a renewed interest in developing materials with a bioactive
        potential that could block the exposed dentinal tubules and subsequently reduce the fluid
        flow within the tubules. Eggshells (EBs) have been investigated in recent years for their
        remineralization capabilities. EB has rich bioavailable calcium content in the form of
        carbonates and oxides. It contains 94% calcium carbonate, 1% calcium phosphate, 1% magnesium
        carbonate, and 4% organic matter. In addition, eggshell provides a cost-effective, renewable,
        and sustainable source of material for EnHAp. A previous study revealed that eggshell powder
        is predicted to be the future of tooth remineralization and highly effective in occluding
        dentinal tubules and reducing dentin hypersensitivity.
  
        Titanium dioxide is one of the few materials that classified as bioactive meaning that it
        enhances bone growth and stable bone bonding with dental implants via precipitation of
        hydroxyapatite on its surface
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Assessment of dentin hypersensitivity
  time frame: from baseline to 2 months after the treatment day.
  description: The pain response will be assessed using the numerical Visual Analogue Scale (VAS, range 0-10), with 0 indicating 'no pain' and 10 indicating 'intolerably severe pain.
  arm group label: first group (A1)
  arm group type: Active Comparator
  description: About 24 patients hypersensitive teeth. So the hypersensitive teeth will be treated with egg shell nanoparticles
  arm group label: second group (A2)
  arm group type: Active Comparator
  description: About 24 patients hypersensitive teeth. treated with the combination therapy of eggshell and TiO2.
  intervention type: Drug
  intervention name: Egg Shell nanoparticles
  description: Evaluate the effects of egg shell nanoparticles combined with Titanium dioxide nanoparticles in the treatment of dentin hypersensitivity at different time intervals.
  arm group label: first group (A1)
  arm group label: second group (A2)
  other name: Titanium dioxide nanoparticles
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Fatma Hussein, Lecturer
  role: Principal Investigator
  affiliation: Al-Azhar Faculty of Dentistary for girls
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Dentin Sensitivity
  mesh term: Hypersensitivity
  mesh term: Titanium dioxide