<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/NCT03763578</url>
  </required_header>
  <id_info>
    <org_study_id>18941</org_study_id>
    <nct_id>NCT03763578</nct_id>
  </id_info>
  <brief_title>Dental Caries Prevention by a Natural Product</brief_title>
  <official_title>Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled 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>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 objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to&#xD;
      standard caries preventive measures for the prevention of new carious lesions in high caries&#xD;
      risk patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research hypothesis (Null hypothesis):&#xD;
&#xD;
      The present clinical trial will be conducted to reject or accept the null hypothesis that&#xD;
      using Licorice extract mouth wash in addition to standard preventive measures will not differ&#xD;
      from using standard preventive measures alone in preventing incidence of new carious lesions.&#xD;
&#xD;
      PICOTS:&#xD;
&#xD;
      P: Population with high caries risk patients&#xD;
&#xD;
      I: Use of licorice.&#xD;
&#xD;
      I2: Use of chlorhexidine&#xD;
&#xD;
      C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).&#xD;
&#xD;
      O.1: Primary outcome is incidence of new carious lesions&#xD;
&#xD;
      T: Time for measurement is 12 months&#xD;
&#xD;
      S: A Randomized controlled clinical trial (Parallel study)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of new carious lesions</measure>
    <time_frame>12 months</time_frame>
    <description>Appearance of new carious lesions within the study duration</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Licorice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>licorice is one of the natural products that is listed by the Food and Drug Administration (FDA) as GRAS (generally regarded as safe) when used as food flavoring and sweetening agent which has an antimicrobial, anti-inflammatory and antiviral activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The &quot;gold standard&quot; of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing interdentally before bed time. (No Mouthwash is used)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Licorice</intervention_name>
    <description>Natural herbal product</description>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_label>Licorice</arm_group_label>
    <other_name>Glycyrrhiza glabra Linn</other_name>
    <other_name>Mulethi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with high caries risk,&#xD;
&#xD;
          -  18-25 years,&#xD;
&#xD;
          -  Males or females,&#xD;
&#xD;
          -  Medically free patients,&#xD;
&#xD;
          -  Patients approving to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before&#xD;
             the examination,&#xD;
&#xD;
          -  Patients had history of professional cleaning in the last 15 days,&#xD;
&#xD;
          -  Patients with exposed pulp,&#xD;
&#xD;
          -  Evidence of parafunctional habits,&#xD;
&#xD;
          -  Patients with developmental dental anomalies,&#xD;
&#xD;
          -  Patients undergoing or will start orthodontic treatment,&#xD;
&#xD;
          -  Patients with removable prosthesis,&#xD;
&#xD;
          -  Periapical Abscess or Fistula.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Choose Any State/Province</state>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sara Mohammed Ahmed Mady</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03763578
org study id: 18941
nct id: NCT03763578
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to
      standard caries preventive measures for the prevention of new carious lesions in high caries
      risk patients.
Research hypothesis (Null hypothesis):

      The present clinical trial will be conducted to reject or accept the null hypothesis that
      using Licorice extract mouth wash in addition to standard preventive measures will not differ
      from using standard preventive measures alone in preventing incidence of new carious lesions.

      PICOTS:

      P: Population with high caries risk patients

      I: Use of licorice.

      I2: Use of chlorhexidine

      C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).

      O.1: Primary outcome is incidence of new carious lesions

      T: Time for measurement is 12 months

      S: A Randomized controlled clinical trial (Parallel study)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of new carious lesions
time frame: 12 months
description: Appearance of new carious lesions within the study duration
arm group label: Licorice
arm group type: Experimental
description: licorice is one of the natural products that is listed by the Food and Drug Administration (FDA) as GRAS (generally regarded as safe) when used as food flavoring and sweetening agent which has an antimicrobial, anti-inflammatory and antiviral activity.
arm group label: Chlorhexidine
arm group type: Active Comparator
description: The "gold standard" of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect.
arm group label: Control Group
arm group type: No Intervention
description: Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing interdentally before bed time. (No Mouthwash is used)
intervention type: Other
intervention name: Licorice
description: Natural herbal product
arm group label: Chlorhexidine
arm group label: Licorice
other name: Glycyrrhiza glabra Linn
other name: Mulethi
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sara Mohammed Ahmed Mady
investigator title: Principal Investigator
mesh term: Dental Caries
sharing ipd: Undecided