<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/NCT03773094</url>
  </required_header>
  <id_info>
    <org_study_id>Guava leaves extract CHX</org_study_id>
    <nct_id>NCT03773094</nct_id>
  </id_info>
  <brief_title>Antibacterial Effect of Guava Leaves Extract Mouthwash Compared to Chlorhexidine Mouthwash in High Caries Risk Patients</brief_title>
  <official_title>Effect of Guava Leaves Extract Mouth Wash on Antibacterial Activity, Salivary pH and Patient Satisfaction Compared to Chlorhexidine Mouth Wash in High Caries Risk Patients: A Randomized Control 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>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>
      This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to&#xD;
      Chlorhexidine mouth wash in high caries risk patients.&#xD;
&#xD;
      Also salivary pH and patient satisfaction to taste will also be tested.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is conducted to evaluate the effect of Guava leaves extract mouth wash on&#xD;
      anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to&#xD;
      taste compared to Chlorhexidine mouth wash.&#xD;
&#xD;
      P: Population with high caries risk patients I: Intervention by Guava leaves extract&#xD;
      mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial&#xD;
      activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient&#xD;
      satisfaction to taste&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-bacterial effect against streptococcus mutans</measure>
    <time_frame>3 months</time_frame>
    <description>Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Salivary pH</measure>
    <time_frame>3 months</time_frame>
    <description>Saliva samples pH will be measured using digital pH meter to evaluate its efficacy in preventing the action of acidogenic bacteria in high caries risk patients.&#xD;
It displays numerical value.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction to taste: questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>The patient will fill a questionnaire to assess patient satisfaction to taste after usage of the mouthwash. Nominal answers</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>High Caries Risk Patients</condition>
  <condition>Antimicrobial Effect</condition>
  <condition>Salivary pH</condition>
  <condition>Patient Satisfaction to Taste</condition>
  <arm_group>
    <arm_group_label>Guava leaves extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A natural product that is prepared as a mouthwash</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>chemical agent Chlorhexidine as a mouthwash</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guava leaves extract</intervention_name>
    <description>Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer&#xD;
•</description>
    <arm_group_label>Guava leaves extract</arm_group_label>
    <other_name>Psidium guajava</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine</intervention_name>
    <description>chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard</description>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <other_name>Chlorhexidine glucnate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. High caries risk patients&#xD;
&#xD;
          2. 18-50 years&#xD;
&#xD;
          3. Healthy cooperative patients&#xD;
&#xD;
          4. Males or Females&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Medically compromised patients&#xD;
&#xD;
          2. Patients with any systemic disease that might affect the salivary flow&#xD;
&#xD;
          3. Allergy to any of the ingredients&#xD;
&#xD;
          4. Patients with physical limitations that might affect normal tooth brushing and mouth&#xD;
             rinsing&#xD;
&#xD;
          5. Presence of intraoral infections&#xD;
&#xD;
          6. Currently using any mouth rinse&#xD;
&#xD;
          7. Smokers&#xD;
&#xD;
          8. Use of antibiotics in the previous 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Engy MM Kassem, Master's degree</last_name>
    <phone>00201000687726</phone>
    <email>engy.mostafa@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed A Khairy, PhD</last_name>
    <email>madelkhairy@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>Gupta D, Nayan S, Tippanawar HK, Patil GI, Jain A, Momin RK, Gupta RK. Are herbal mouthwash efficacious over chlorhexidine on the dental plaque? Pharmacognosy Res. 2015 Jul-Sep;7(3):277-81. doi: 10.4103/0974-8490.155874.</citation>
    <PMID>26130940</PMID>
  </reference>
  <reference>
    <citation>Ravi K, Divyashree P. Psidium guajava: A review on its potential as an adjunct in treating periodontal disease. Pharmacogn Rev. 2014 Jul;8(16):96-100. doi: 10.4103/0973-7847.134233.</citation>
    <PMID>25125881</PMID>
  </reference>
  <reference>
    <citation>Singla S, Malhotra R, Nd S, Saxena S. Antibacterial Efficacy of Mouthwash Prepared from Pomegranate, Grape Seed and Guava Extracts against Oral Streptococci: An in Vivo Study. J Clin Pediatr Dent. 2018;42(2):109-113. doi: 10.17796/1053-4628-42.2.5. Epub 2017 Oct 31.</citation>
    <PMID>29087796</PMID>
  </reference>
  <reference>
    <citation>Shah S, Bargale S, Dave BH, Deshpande A, Kariya PB, Karri A. Comparison of Antimicrobial Efficacy of (between) 0.2% Chlorhexidine and Herbal Mouthwash on Salivary Streptococcus mutans: A Randomized Controlled Pilot Study. Contemp Clin Dent. 2018 Jul-Sep;9(3):440-445. doi: 10.4103/ccd.ccd_264_18.</citation>
    <PMID>30166841</PMID>
  </reference>
  <reference>
    <citation>Jain I, Jain P. Comparative evaluation of antimicrobial efficacy of three different formulations of mouth rinses with multi-herbal mouth rinse. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):315-23. doi: 10.4103/0970-4388.191409.</citation>
    <PMID>27681394</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Engy Mostafa Magdy Abdou Ahmed Kassem</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03773094
org study id: Guava leaves extract CHX
nct id: NCT03773094
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is to test the antibacterial effect of Guava leaves extract mouth wash compared to
      Chlorhexidine mouth wash in high caries risk patients.

      Also salivary pH and patient satisfaction to taste will also be tested.
This study is conducted to evaluate the effect of Guava leaves extract mouth wash on
      anti-bacterial activity against streptococcus mutans, salivary pH and patient satisfaction to
      taste compared to Chlorhexidine mouth wash.

      P: Population with high caries risk patients I: Intervention by Guava leaves extract
      mouthwash C: Control is Chlorhexidine mouthwash O1: The primary outcome is antibacterial
      activity. O2: The secondary outcome is salivary pH O3: The tertiary outcome is patient
      satisfaction to taste
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Anti-bacterial effect against streptococcus mutans
time frame: 3 months
description: Antimicrobial effect against streptococcus mutans: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units
measure: Salivary pH
time frame: 3 months
description: Saliva samples pH will be measured using digital pH meter to evaluate its efficacy in preventing the action of acidogenic bacteria in high caries risk patients.
It displays numerical value.
measure: Patient satisfaction to taste: questionnaire
time frame: 3 months
description: The patient will fill a questionnaire to assess patient satisfaction to taste after usage of the mouthwash. Nominal answers
arm group label: Guava leaves extract
arm group type: Experimental
description: A natural product that is prepared as a mouthwash
arm group label: Chlorhexidine
arm group type: Active Comparator
description: chemical agent Chlorhexidine as a mouthwash
intervention type: Drug
intervention name: Guava leaves extract
description: Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer
•
arm group label: Guava leaves extract
other name: Psidium guajava
intervention type: Drug
intervention name: Chlorhexidine
description: chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
arm group label: Chlorhexidine
other name: Chlorhexidine glucnate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Engy MM Kassem, Master's degree
phone: 00201000687726
email: engy.mostafa@dentistry.cu.edu.eg
last name: Mohamed A Khairy, PhD
email: madelkhairy@dentistry.cu.edu.eg
citation: Gupta D, Nayan S, Tippanawar HK, Patil GI, Jain A, Momin RK, Gupta RK. Are herbal mouthwash efficacious over chlorhexidine on the dental plaque? Pharmacognosy Res. 2015 Jul-Sep;7(3):277-81. doi: 10.4103/0974-8490.155874.
PMID: 26130940
citation: Ravi K, Divyashree P. Psidium guajava: A review on its potential as an adjunct in treating periodontal disease. Pharmacogn Rev. 2014 Jul;8(16):96-100. doi: 10.4103/0973-7847.134233.
PMID: 25125881
citation: Singla S, Malhotra R, Nd S, Saxena S. Antibacterial Efficacy of Mouthwash Prepared from Pomegranate, Grape Seed and Guava Extracts against Oral Streptococci: An in Vivo Study. J Clin Pediatr Dent. 2018;42(2):109-113. doi: 10.17796/1053-4628-42.2.5. Epub 2017 Oct 31.
PMID: 29087796
citation: Shah S, Bargale S, Dave BH, Deshpande A, Kariya PB, Karri A. Comparison of Antimicrobial Efficacy of (between) 0.2% Chlorhexidine and Herbal Mouthwash on Salivary Streptococcus mutans: A Randomized Controlled Pilot Study. Contemp Clin Dent. 2018 Jul-Sep;9(3):440-445. doi: 10.4103/ccd.ccd_264_18.
PMID: 30166841
citation: Jain I, Jain P. Comparative evaluation of antimicrobial efficacy of three different formulations of mouth rinses with multi-herbal mouth rinse. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):315-23. doi: 10.4103/0970-4388.191409.
PMID: 27681394
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Engy Mostafa Magdy Abdou Ahmed Kassem
investigator title: Assistant Lecturer
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
sharing ipd: No