<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/NCT04422860</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-2</org_study_id>
    <nct_id>NCT04422860</nct_id>
  </id_info>
  <brief_title>Remineralization Efficacy of Gum Arabic Varnish.</brief_title>
  <official_title>Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled 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 this study is to evaluate the remineralizing capacity of Gum Arabic varnish and&#xD;
      its implementation into clinical practice.&#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">November 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>Remineralization through determination of lesion progression or regression</measure>
    <time_frame>Change from baseline at 3,6, 9 months</time_frame>
    <description>Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caries lesion activity assessment</measure>
    <time_frame>Change from baseline at 3,6, 9 months</time_frame>
    <description>Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Caries,Dental</condition>
  <condition>Remineralization</condition>
  <condition>White Spot Lesion</condition>
  <arm_group>
    <arm_group_label>Gum Arabic varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium Fluoride varnish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The gold standard remineralizing agent recommended by the guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10% w/v CPP-ACP, 5% sodium fluoride varnish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CPP-ACP is the most studied non fluoride remineralizing agent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gum Arabic varnish</intervention_name>
    <description>Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).</description>
    <arm_group_label>Gum Arabic varnish</arm_group_label>
    <other_name>Acacia senegal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Proflourid Varnish,VOCO</intervention_name>
    <description>5% NaF varnish</description>
    <arm_group_label>Sodium Fluoride varnish</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MI Varnish,GC Japan Inc.</intervention_name>
    <description>CPP-ACP with fluoride based varnish</description>
    <arm_group_label>10% w/v CPP-ACP, 5% sodium fluoride varnish</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with initial carious lesions.&#xD;
&#xD;
          -  Proper Oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a compromised medical history.&#xD;
&#xD;
          -  Patients with active severe periodontal disease.&#xD;
&#xD;
          -  Patients with hypoplastic or hypomineralized teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rawda H. A.ElAziz, Post Phd</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer at faculty of Dentistry- Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rasha R Hassan</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant Professor at faculty of Dentistry- Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed H. Samaha, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Master's Degree student at faculty of Dentistry- Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rawda H. A.ElAziz, Post Phd</last_name>
    <phone>00201001097200</phone>
    <email>rawda.hesham@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed H. Samaha, BSc</last_name>
    <email>Ahmed.hesham@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <zip>11331</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8.</citation>
    <PMID>30296788</PMID>
  </reference>
  <reference>
    <citation>Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.</citation>
    <PMID>18036508</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hesham samaha</investigator_full_name>
    <investigator_title>Master's Degree Student- Faculty of Dentistry</investigator_title>
  </responsible_party>
  <keyword>Initial carious lesion</keyword>
  <keyword>Gum Arabic</keyword>
  <keyword>Remineralization power</keyword>
  <keyword>fluoride varnish</keyword>
  <keyword>Mi varnish</keyword>
  <keyword>Acacia senegal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</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/NCT04422860
org study id: CEBD-2
nct id: NCT04422860
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and
      its implementation into clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Remineralization through determination of lesion progression or regression
time frame: Change from baseline at 3,6, 9 months
description: Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.
measure: Caries lesion activity assessment
time frame: Change from baseline at 3,6, 9 months
description: Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)
arm group label: Gum Arabic varnish
arm group type: Experimental
description: Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization.
arm group label: Sodium Fluoride varnish
arm group type: Active Comparator
description: The gold standard remineralizing agent recommended by the guidelines.
arm group label: 10% w/v CPP-ACP, 5% sodium fluoride varnish
arm group type: Active Comparator
description: CPP-ACP is the most studied non fluoride remineralizing agent.
intervention type: Drug
intervention name: Gum Arabic varnish
description: Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).
arm group label: Gum Arabic varnish
other name: Acacia senegal
intervention type: Drug
intervention name: Proflourid Varnish,VOCO
description: 5% NaF varnish
arm group label: Sodium Fluoride varnish
intervention type: Drug
intervention name: MI Varnish,GC Japan Inc.
description: CPP-ACP with fluoride based varnish
arm group label: 10% w/v CPP-ACP, 5% sodium fluoride varnish
criteria: 
gender: All
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rawda H. A.ElAziz, Post Phd
role: Study Director
affiliation: Lecturer at faculty of Dentistry- Cairo University
last name: Rasha R Hassan
role: Study Chair
affiliation: Assistant Professor at faculty of Dentistry- Cairo University
last name: Ahmed H. Samaha, BSc
role: Principal Investigator
affiliation: Master's Degree student at faculty of Dentistry- Cairo University
last name: Rawda H. A.ElAziz, Post Phd
phone: 00201001097200
email: rawda.hesham@dentistry.cu.edu.eg
last name: Ahmed H. Samaha, BSc
email: Ahmed.hesham@dentistry.cu.edu.eg
facility: 
country: Egypt
citation: Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8.
PMID: 30296788
citation: Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.
PMID: 18036508
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hesham samaha
investigator title: Master's Degree Student- Faculty of Dentistry
mesh term: Dental Caries