<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/NCT04401280</url>
  </required_header>
  <id_info>
    <org_study_id>WSL treatment</org_study_id>
    <nct_id>NCT04401280</nct_id>
  </id_info>
  <brief_title>Bioactive Glass in the Treatment of Enamel White Spot Lesions</brief_title>
  <official_title>Effectiveness of Novel Bioactive Glass in the Treatment of Enamel White Spot Lesions : A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rania Salah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alexandria 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison&#xD;
      to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel&#xD;
      white spot lesions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in White spot lesions dimension</measure>
    <time_frame>6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)</time_frame>
    <description>Quantified using computer-assisted analysis based on digital intraoral photographs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in lesion fluorescence</measure>
    <time_frame>6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)</time_frame>
    <description>evaluated using diode laser fluorescence device (Diagnodent)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>White Spot Lesion of Tooth</condition>
  <arm_group>
    <arm_group_label>BiominF®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Test group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Novamin®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Test group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPP-ACP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BiominF</intervention_name>
    <description>in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached</description>
    <arm_group_label>BiominF®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Novamin</intervention_name>
    <description>in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached</description>
    <arm_group_label>Novamin®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPP-ACP</intervention_name>
    <description>applied in accordance with the manufacturer's specifications</description>
    <arm_group_label>CPP-ACP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not less than 1 white spot lesion on the labial surface of teeth in the anterior&#xD;
             region with code 2 International Caries Detection and Assessment System II (ICDAS-II)&#xD;
             or less&#xD;
&#xD;
          -  Absence of any active periodontal disease.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity/allergy to study products and/or materials used&#xD;
&#xD;
          -  teeth having deep carious lesions or extensive restorations&#xD;
&#xD;
          -  Unwillingness to be randomly assigned to 1 of the 3 treatment groups&#xD;
&#xD;
          -  Advanced periodontal disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 11, 2021</last_update_submitted>
  <last_update_submitted_qc>October 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Rania Salah</investigator_full_name>
    <investigator_title>Clinical instructor and Principal investigator at conservative dentistry department</investigator_title>
  </responsible_party>
  <keyword>Bioactive glass</keyword>
  <keyword>CPP-ACP</keyword>
  <keyword>Remineralization</keyword>
  <keyword>White spot lesions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exanthema</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/NCT04401280
org study id: WSL treatment
nct id: NCT04401280
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison
      to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel
      white spot lesions
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in White spot lesions dimension
time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
description: Quantified using computer-assisted analysis based on digital intraoral photographs
measure: change in lesion fluorescence
time frame: 6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)
description: evaluated using diode laser fluorescence device (Diagnodent)
arm group label: BiominF®
arm group type: Active Comparator
description: Test group
arm group label: Novamin®
arm group type: Active Comparator
description: Test group
arm group label: CPP-ACP
arm group type: Active Comparator
description: Control group
intervention type: Drug
intervention name: BiominF
description: in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
arm group label: BiominF®
intervention type: Drug
intervention name: Novamin
description: in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached
arm group label: Novamin®
intervention type: Drug
intervention name: CPP-ACP
description: applied in accordance with the manufacturer's specifications
arm group label: CPP-ACP
criteria: 
gender: All
minimum age: 14 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Alexandria University
investigator full name: Rania Salah
investigator title: Clinical instructor and Principal investigator at conservative dentistry department
mesh term: Exanthema