<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/NCT04485520</url>
  </required_header>
  <id_info>
    <org_study_id>00140</org_study_id>
    <nct_id>NCT04485520</nct_id>
  </id_info>
  <brief_title>Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans</brief_title>
  <official_title>Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans in Students of the Faculty of Dentistry in the Year 2018</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julieta María Méndez Romero</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional de Caaguazu</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>
      Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality,&#xD;
      amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different&#xD;
      bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The&#xD;
      objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling)&#xD;
      as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National&#xD;
      University of Caaguazú in 2018.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific objectives&#xD;
&#xD;
        -  To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on&#xD;
           Streptococcus Mutans by age and sex grouping.&#xD;
&#xD;
        -  To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on&#xD;
           the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the&#xD;
           experimental group.&#xD;
&#xD;
        -  Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus&#xD;
           Mutans before, after 10 minutes and 8 days of use in the control group.&#xD;
&#xD;
        -  Compare the count of Colony Forming Units (CFU) between both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">October 21, 2017</completion_date>
  <primary_completion_date type="Actual">October 21, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Colony Forming units (Stage 1)</measure>
    <time_frame>thorough study completion, an average of 24 hours</time_frame>
    <description>Before Intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Colony Forming units (Stage 2)</measure>
    <time_frame>10 minutes after mouthwash use</time_frame>
    <description>After Intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Colony Forming units (Stage 3)</measure>
    <time_frame>8 days after mouthwash use</time_frame>
    <description>After Intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Streptococcus, Other Specified Group</condition>
  <condition>Dental Plaque</condition>
  <arm_group>
    <arm_group_label>Carica Papaya extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carica Papaya at 3%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.12% chlorhexidine mouthwash formulation (commercially available)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CARICA PAPAYA MOUTHWASH</intervention_name>
    <description>Each application was 10 ml. applied for 1 minute, once a day for 8 days</description>
    <arm_group_label>Carica Papaya extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHLORHEXIDINE MOUTHWASH</intervention_name>
    <description>Each application was 10 ml. applied for 1 minute, once a day for 8 days</description>
    <arm_group_label>Chlorhexidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants that signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic to carica papaya&#xD;
&#xD;
          -  ongoing medical or dental treatment that could interfere with the results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diego Céspedes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Facultad de Odontología, Universidad Nacional de Caaguazu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulises A Villasanti Torales</last_name>
    <role>Study Director</role>
    <affiliation>Facultad de Odontologia, Universidad Nacional de Caaguazu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Facultad de Odontología Universidad Nacional de Caaguazú</name>
      <address>
        <city>Coronel Oviedo</city>
        <state>International</state>
        <zip>595</zip>
        <country>Paraguay</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Paraguay</country>
  </location_countries>
  <reference>
    <citation>Saliasi I, Llodra JC, Bravo M, Tramini P, Dussart C, Viennot S, Carrouel F. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Nov 27;15(12):2660. doi: 10.3390/ijerph15122660.</citation>
    <PMID>30486374</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional de Caaguazu</investigator_affiliation>
    <investigator_full_name>Julieta María Méndez Romero</investigator_full_name>
    <investigator_title>Head of Writting and Publication Department, Regional Health Research Institute</investigator_title>
  </responsible_party>
  <keyword>Saliva</keyword>
  <keyword>dental plaque</keyword>
  <keyword>streptococcus mutans</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>By email</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>From the time the protocol is available in clinical trials.gov and with no limit of time</ipd_time_frame>
    <ipd_access_criteria>Researchers that want to know about the study and use the protocol</ipd_access_criteria>
  </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/NCT04485520
org study id: 00140
nct id: NCT04485520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality,
      amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different
      bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The
      objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling)
      as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National
      University of Caaguazú in 2018.
Specific objectives

        -  To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on
           Streptococcus Mutans by age and sex grouping.

        -  To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on
           the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the
           experimental group.

        -  Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus
           Mutans before, after 10 minutes and 8 days of use in the control group.

        -  Compare the count of Colony Forming Units (CFU) between both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of Colony Forming units (Stage 1)
time frame: thorough study completion, an average of 24 hours
description: Before Intervention
measure: Number of Colony Forming units (Stage 2)
time frame: 10 minutes after mouthwash use
description: After Intervention
measure: Number of Colony Forming units (Stage 3)
time frame: 8 days after mouthwash use
description: After Intervention
arm group label: Carica Papaya extract
arm group type: Experimental
description: Carica Papaya at 3%
arm group label: Chlorhexidine
arm group type: Active Comparator
description: 0.12% chlorhexidine mouthwash formulation (commercially available)
intervention type: Other
intervention name: CARICA PAPAYA MOUTHWASH
description: Each application was 10 ml. applied for 1 minute, once a day for 8 days
arm group label: Carica Papaya extract
intervention type: Other
intervention name: CHLORHEXIDINE MOUTHWASH
description: Each application was 10 ml. applied for 1 minute, once a day for 8 days
arm group label: Chlorhexidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Diego Céspedes
role: Principal Investigator
affiliation: Facultad de Odontología, Universidad Nacional de Caaguazu
last name: Ulises A Villasanti Torales
role: Study Director
affiliation: Facultad de Odontologia, Universidad Nacional de Caaguazu
facility: 
country: Paraguay
citation: Saliasi I, Llodra JC, Bravo M, Tramini P, Dussart C, Viennot S, Carrouel F. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Nov 27;15(12):2660. doi: 10.3390/ijerph15122660.
PMID: 30486374
responsible party type: Sponsor-Investigator
investigator affiliation: Universidad Nacional de Caaguazu
investigator full name: Julieta María Méndez Romero
investigator title: Head of Writting and Publication Department, Regional Health Research Institute
mesh term: Dental Plaque
mesh term: Chlorhexidine
sharing ipd: Yes
ipd description: By email
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: From the time the protocol is available in clinical trials.gov and with no limit of time
ipd access criteria: Researchers that want to know about the study and use the protocol