<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/NCT03771443</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-12-01</org_study_id>
    <nct_id>NCT03771443</nct_id>
  </id_info>
  <brief_title>Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease</brief_title>
  <official_title>Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)</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>No</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>
      Celiac disease (CD) is the most common genetically based food intolerance in the world, with&#xD;
      a prevalence among approximately 1% of the general population (Guandalini &amp; Assiri, 2014). CD&#xD;
      is a frequent disorder among Egyptian children, both in the general population and in at-risk&#xD;
      groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases&#xD;
      per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong&#xD;
      adherence to a strict gluten free diet (GFD) remains the only available treatment for&#xD;
      patients with CD and typically results in a complete return to health. Nevertheless, gluten&#xD;
      is not found only in diet, Gluten is commonly used as a binder in products like medication,&#xD;
      cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes&#xD;
      and other oral health products and it can be swallowed by mistake and initiate immune&#xD;
      response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the&#xD;
      Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will&#xD;
      cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste&#xD;
      in Egypt has become mandatory.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      production of an experimental gluten free toothpaste and providing it for children with&#xD;
      celiac disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2019</start_date>
  <completion_date type="Actual">January 21, 2020</completion_date>
  <primary_completion_date type="Actual">January 21, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcerative events</measure>
    <time_frame>Six months</time_frame>
    <description>Reporting from the parent (Yes or No)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammation or ulceration</measure>
    <time_frame>six months</time_frame>
    <description>visual (Yes or No)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Gluten Sensitivity</condition>
  <arm_group>
    <arm_group_label>gluten free toothpaste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>experimental gluten free toothpaste</intervention_name>
    <description>we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .</description>
    <arm_group_label>gluten free toothpaste</arm_group_label>
    <other_name>natural toothpaste</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age above 6 yeas.&#xD;
&#xD;
          2. Erupting lower 6.&#xD;
&#xD;
          3. Can spit the toothpaste.&#xD;
&#xD;
          4. Diagnosed as a celiac patient(pathology&amp;serology)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With a history of allergy to any ingredient present in the toothpaste to be used for&#xD;
             treatment&#xD;
&#xD;
          2. The presence of serious medical conditions or a transmissible disease such as&#xD;
             malignant disease, hepatitis, AIDS etc.&#xD;
&#xD;
          3. Children whose parents had no home or mobile phone to enable post-operative contact.&#xD;
&#xD;
          4. Parent that will not sign the consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eman A Abdelhameed, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident at Pediatric Dentistry and Dental Public Health Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fatma KI Abdelgawad, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant Professor at Pediatric Dentistry and Dental Public Health Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kamal M El Motayam, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Emeritus Professor at Pediatric Dentistry and Dental Public Health Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Cairo University</name>
      <address>
        <city>Giza</city>
        <state>Al Manial, Cairo, Egypt</state>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 8, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Eman Adel Abd Elhameed</investigator_full_name>
    <investigator_title>master degree student</investigator_title>
  </responsible_party>
  <keyword>Gluten-free toothpaste,celiac disease, GFD, children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</mesh_term>
  </condition_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/NCT03771443
org study id: CEBD-CU-2018-12-01
nct id: NCT03771443
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Celiac disease (CD) is the most common genetically based food intolerance in the world, with
      a prevalence among approximately 1% of the general population (Guandalini & Assiri, 2014). CD
      is a frequent disorder among Egyptian children, both in the general population and in at-risk
      groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases
      per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong
      adherence to a strict gluten free diet (GFD) remains the only available treatment for
      patients with CD and typically results in a complete return to health. Nevertheless, gluten
      is not found only in diet, Gluten is commonly used as a binder in products like medication,
      cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes
      and other oral health products and it can be swallowed by mistake and initiate immune
      response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the
      Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will
      cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste
      in Egypt has become mandatory.
production of an experimental gluten free toothpaste and providing it for children with
      celiac disease
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Ulcerative events
time frame: Six months
description: Reporting from the parent (Yes or No)
measure: Inflammation or ulceration
time frame: six months
description: visual (Yes or No)
arm group label: gluten free toothpaste
arm group type: Experimental
description: experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months
intervention type: Drug
intervention name: experimental gluten free toothpaste
description: we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .
arm group label: gluten free toothpaste
other name: natural toothpaste
criteria: 
gender: All
minimum age: 6 Years
maximum age: 15 Years
healthy volunteers: No
last name: Eman A Abdelhameed, BSc
role: Principal Investigator
affiliation: Resident at Pediatric Dentistry and Dental Public Health Department
last name: Fatma KI Abdelgawad, PhD
role: Study Chair
affiliation: Assistant Professor at Pediatric Dentistry and Dental Public Health Department
last name: Kamal M El Motayam, PhD
role: Study Director
affiliation: Emeritus Professor at Pediatric Dentistry and Dental Public Health Department
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Eman Adel Abd Elhameed
investigator title: master degree student
mesh term: Celiac Disease