<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/NCT04410666</url>
  </required_header>
  <id_info>
    <org_study_id>00139</org_study_id>
    <nct_id>NCT04410666</nct_id>
  </id_info>
  <brief_title>Antibacterial Effect of the Infusion of Green Tea Used as a Mouthwash on Saliva and Bacterial Plaque</brief_title>
  <official_title>Antibacterial Effect of the Infusion of Green Tea (Camellia Sinensis) as a Mouthwash on Saliva and Bacterial Plaque</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>
      Given that the participation of oral microorganisms in the development of the most prevalent&#xD;
      pathologies of the oral cavity is unquestionable, efforts have been made to create agents&#xD;
      that allow controlling these bacteria. The objective of this work was to analyze the&#xD;
      antibacterial effect of green tea infusion used as a mouthwash on saliva and bacterial&#xD;
      plaque. The green tea infusion was prepared at 13% at approximately 90 ° C, being the same&#xD;
      applied to 14 participants from the 1st to the 5th grade (experimental group); and to other&#xD;
      14 participants the placebo was applied (control group). The antibacterial effect was&#xD;
      determined by counting the colony forming units (CFU) in the cultures of samples of bacterial&#xD;
      plaque and saliva, taken before the application of the infusion and immediately after.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral diseases, including dental caries, is one of the most prevalent in the population. It is&#xD;
      multifactorial and originates from the formation of the bacterial plaque and its&#xD;
      non-elimination by physical and chemical hygiene methods.&#xD;
&#xD;
      The use of chemical agents to aid in the control of Bacterial Plaque has been the subject of&#xD;
      study in many investigations. Today there is a variety of elements that can be use to carry&#xD;
      out proper oral hygiene, such as toothbrushes, toothpastes, dental floss and mouthwash, all&#xD;
      of them in a wide variety.&#xD;
&#xD;
      Often the lack of accessibility to these means problems in the hygiene in the population,&#xD;
      either due to the lack of knowledge or the cost of obtaining them.&#xD;
&#xD;
      Therefore, the objective of analyzing the antibacterial effect of the infusion of green tea&#xD;
      (camellia sinensis) used as a mouthwash on saliva and bacterial plaque was presented. The&#xD;
      proposed research topic is relevant, since if green tea (camellia sinensis) is found to&#xD;
      produce positive effects on bacterial plaque, it would serve to prevent its formation, thus&#xD;
      helping to improve dental hygiene with an easy acquisition product and lower cost compared to&#xD;
      other mouthwashes offered in the market, constituting a natural mouthwash.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2016</start_date>
  <completion_date type="Actual">September 21, 2016</completion_date>
  <primary_completion_date type="Actual">September 21, 2016</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>
    <intervention_model_description>Experimental group: an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C.&#xD;
Control group: distilled water, in sterile glass containers. Each application was 10 ml. applied for 1 minute.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>It was single blind, since the patient did not wat treatment was receiving. It was used a placebo.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial plaque Stage 1 (Before intervention)</measure>
    <time_frame>thorough study completion, an average of 24 hours</time_frame>
    <description>The measure was done with the count of Colony forming units</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bacterial plaque Stage 2 (After intervention)</measure>
    <time_frame>1 minute after mouthwash use</time_frame>
    <description>The measure was done with the count of Colony forming units</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antimicrobial effect</measure>
    <time_frame>up to 24 hours, thorough study completion</time_frame>
    <description>The measure was done with the difference in count of Colony forming units before and after intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Dental Plaque</condition>
  <arm_group>
    <arm_group_label>GREEN TEA MOUTH WASH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>distilled water, in sterile glass containers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Green Tea mouthwash</intervention_name>
    <description>an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C, in sterile glass containers.&#xD;
Each application was 10 ml. applied for 1 minute.</description>
    <arm_group_label>GREEN TEA MOUTH WASH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Mouthwash</intervention_name>
    <description>distilled water</description>
    <arm_group_label>Placebo</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 green tea (Camellia sinensis)&#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>Jazmin Servin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Facultad de Odontologia, Universidad Nacional de Caaguazu</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nelson Portillo</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 Caaguazu</name>
      <address>
        <city>Coronel Oviedo</city>
        <state>Caaguazu</state>
        <zip>3300</zip>
        <country>Paraguay</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Paraguay</country>
  </location_countries>
  <reference>
    <citation>Ardakani MR, Golmohammadi S, Ayremlou S, Taheri S, Daneshvar S, Meimandi M. Antibacterial effect of Iranian green-tea-containing mouthrinse vs chlorhexidine 0.2%: an in vitro study. Oral Health Prev Dent. 2014;12(2):157-62. doi: 10.3290/j.ohpd.a31663.</citation>
    <PMID>24624389</PMID>
  </reference>
  <reference>
    <citation>Megalaa N, Thirumurugan K, Kayalvizhi G, Sajeev R, Kayalvizhi EB, Ramesh V, Vargeese A. A comparative evaluation of the anticaries efficacy of herbal extracts (Tulsi and Black myrobalans) and sodium fluoride as mouthrinses in children: A randomized controlled trial. Indian J Dent Res. 2018 Nov-Dec;29(6):760-767. doi: 10.4103/ijdr.IJDR_790_16.</citation>
    <PMID>30589005</PMID>
  </reference>
  <reference>
    <citation>Ronanki S, Kulkarni S, Hemalatha R, Kumar M, Reddy P. Efficacy of commercially available chlorhexidine mouthrinses against specific oral microflora. Indian J Dent Res. 2016 Jan-Feb;27(1):48-53. doi: 10.4103/0970-9290.179816.</citation>
    <PMID>27054861</PMID>
  </reference>
  <reference>
    <citation>Hajiahmadi M, Yegdaneh A, Homayoni A, Parishani H, Moshkelgosha H, Salari-Moghaddam R. Comparative Evaluation of Efficacy of &quot;Green Tea&quot; and &quot;Green Tea with Xylitol&quot; Mouthwashes on the Salivary Streptococcus mutans and Lactobacillus Colony Count in Children: A Randomized Clinical Trial. J Contemp Dent Pract. 2019 Oct 1;20(10):1190-1194.</citation>
    <PMID>31883255</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 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>Mouthwash</keyword>
  <keyword>Green Tea</keyword>
  <keyword>Oral bacteria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
  </condition_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_info_type>Informed Consent Form (ICF)</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/NCT04410666
org study id: 00139
nct id: NCT04410666
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Given that the participation of oral microorganisms in the development of the most prevalent
      pathologies of the oral cavity is unquestionable, efforts have been made to create agents
      that allow controlling these bacteria. The objective of this work was to analyze the
      antibacterial effect of green tea infusion used as a mouthwash on saliva and bacterial
      plaque. The green tea infusion was prepared at 13% at approximately 90 ° C, being the same
      applied to 14 participants from the 1st to the 5th grade (experimental group); and to other
      14 participants the placebo was applied (control group). The antibacterial effect was
      determined by counting the colony forming units (CFU) in the cultures of samples of bacterial
      plaque and saliva, taken before the application of the infusion and immediately after.
Oral diseases, including dental caries, is one of the most prevalent in the population. It is
      multifactorial and originates from the formation of the bacterial plaque and its
      non-elimination by physical and chemical hygiene methods.

      The use of chemical agents to aid in the control of Bacterial Plaque has been the subject of
      study in many investigations. Today there is a variety of elements that can be use to carry
      out proper oral hygiene, such as toothbrushes, toothpastes, dental floss and mouthwash, all
      of them in a wide variety.

      Often the lack of accessibility to these means problems in the hygiene in the population,
      either due to the lack of knowledge or the cost of obtaining them.

      Therefore, the objective of analyzing the antibacterial effect of the infusion of green tea
      (camellia sinensis) used as a mouthwash on saliva and bacterial plaque was presented. The
      proposed research topic is relevant, since if green tea (camellia sinensis) is found to
      produce positive effects on bacterial plaque, it would serve to prevent its formation, thus
      helping to improve dental hygiene with an easy acquisition product and lower cost compared to
      other mouthwashes offered in the market, constituting a natural mouthwash.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental group: an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C.
Control group: distilled water, in sterile glass containers. Each application was 10 ml. applied for 1 minute.
primary purpose: Prevention
masking: Single (Participant)
masking description: It was single blind, since the patient did not wat treatment was receiving. It was used a placebo.
measure: Bacterial plaque Stage 1 (Before intervention)
time frame: thorough study completion, an average of 24 hours
description: The measure was done with the count of Colony forming units
measure: Bacterial plaque Stage 2 (After intervention)
time frame: 1 minute after mouthwash use
description: The measure was done with the count of Colony forming units
measure: Antimicrobial effect
time frame: up to 24 hours, thorough study completion
description: The measure was done with the difference in count of Colony forming units before and after intervention
arm group label: GREEN TEA MOUTH WASH
arm group type: Experimental
description: an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C.
arm group label: Placebo
arm group type: Placebo Comparator
description: distilled water, in sterile glass containers.
intervention type: Other
intervention name: Green Tea mouthwash
description: an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C, in sterile glass containers.
Each application was 10 ml. applied for 1 minute.
arm group label: GREEN TEA MOUTH WASH
intervention type: Other
intervention name: Placebo Mouthwash
description: distilled water
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jazmin Servin
role: Principal Investigator
affiliation: Facultad de Odontologia, Universidad Nacional de Caaguazu
last name: Nelson Portillo
role: Study Director
affiliation: Facultad de Odontologia, Universidad Nacional de Caaguazu
facility: 
country: Paraguay
citation: Ardakani MR, Golmohammadi S, Ayremlou S, Taheri S, Daneshvar S, Meimandi M. Antibacterial effect of Iranian green-tea-containing mouthrinse vs chlorhexidine 0.2%: an in vitro study. Oral Health Prev Dent. 2014;12(2):157-62. doi: 10.3290/j.ohpd.a31663.
PMID: 24624389
citation: Megalaa N, Thirumurugan K, Kayalvizhi G, Sajeev R, Kayalvizhi EB, Ramesh V, Vargeese A. A comparative evaluation of the anticaries efficacy of herbal extracts (Tulsi and Black myrobalans) and sodium fluoride as mouthrinses in children: A randomized controlled trial. Indian J Dent Res. 2018 Nov-Dec;29(6):760-767. doi: 10.4103/ijdr.IJDR_790_16.
PMID: 30589005
citation: Ronanki S, Kulkarni S, Hemalatha R, Kumar M, Reddy P. Efficacy of commercially available chlorhexidine mouthrinses against specific oral microflora. Indian J Dent Res. 2016 Jan-Feb;27(1):48-53. doi: 10.4103/0970-9290.179816.
PMID: 27054861
citation: Hajiahmadi M, Yegdaneh A, Homayoni A, Parishani H, Moshkelgosha H, Salari-Moghaddam R. Comparative Evaluation of Efficacy of "Green Tea" and "Green Tea with Xylitol" Mouthwashes on the Salivary Streptococcus mutans and Lactobacillus Colony Count in Children: A Randomized Clinical Trial. J Contemp Dent Pract. 2019 Oct 1;20(10):1190-1194.
PMID: 31883255
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
sharing ipd: Yes
ipd description: By email
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
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