<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/NCT04484792</url>
  </required_header>
  <id_info>
    <org_study_id>TUCDREC/20181112/AlRehaili</org_study_id>
    <nct_id>NCT04484792</nct_id>
  </id_info>
  <brief_title>Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis</brief_title>
  <official_title>Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taibah University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taibah University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation will study the effect of green tea mouthwash as an adjunctive therapy to&#xD;
      mechanical treatment on gingival health, and whether it has any side effects. This study also&#xD;
      aims at increasing the awareness among health professionals and the community regarding the&#xD;
      benefits of natural herbal products such as green tea on oral health, opposed to common&#xD;
      chemical products. This may provide an efficient alternative for people who are sensitive to&#xD;
      certain chemical products or who have limited sources of income and cannot afford expensive&#xD;
      treatment of dental problems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 27, 2020</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plaque control record</measure>
    <time_frame>over 27 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>gingival bleeding index</measure>
    <time_frame>over 27 days</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Plaque Induced Gingivitis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>green tea mouthwash</intervention_name>
    <description>green tea bags in 100 ml warm water for 5 min</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>green tea mouthwash</intervention_name>
    <description>, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Plain water</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients attending the clinics at the Taibah University Dental College and Hospital&#xD;
             (TUDCH)&#xD;
&#xD;
          -  Age from 18 - 35 years&#xD;
&#xD;
          -  Generalized plaque-induced gingivitis (GBI &gt; 85%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any systemic diseases&#xD;
&#xD;
          -  Patients under regular medication (e.g. Contraceptives, Hormone- Replacement Therapy)&#xD;
&#xD;
          -  Pregnant or breast-feeding patients&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Periodontitis patients&#xD;
&#xD;
          -  Patients who received any form of periodontal therapy within the last 6 months&#xD;
&#xD;
          -  Patients who were under antibiotic therapy the past month&#xD;
&#xD;
          -  Patients using regular mouthwash or other chemical plaque control agents (e.g. Miswak)&#xD;
             except for regular toothpaste (Note: toothpastes with specific anti-inflammatory&#xD;
             properties are excluded)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taibah University</name>
      <address>
        <city>Al Madīnah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taibah University</investigator_affiliation>
    <investigator_full_name>Alhanouf M. AlRehaili</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>Gingivitis</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/NCT04484792
org study id: TUCDREC/20181112/AlRehaili
nct id: NCT04484792
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This investigation will study the effect of green tea mouthwash as an adjunctive therapy to
      mechanical treatment on gingival health, and whether it has any side effects. This study also
      aims at increasing the awareness among health professionals and the community regarding the
      benefits of natural herbal products such as green tea on oral health, opposed to common
      chemical products. This may provide an efficient alternative for people who are sensitive to
      certain chemical products or who have limited sources of income and cannot afford expensive
      treatment of dental problems.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: plaque control record
time frame: over 27 days
measure: gingival bleeding index
time frame: over 27 days
arm group label: Group A
arm group type: Experimental
arm group label: Group B
arm group type: Experimental
arm group label: Group C
arm group type: Placebo Comparator
intervention type: Other
intervention name: green tea mouthwash
description: green tea bags in 100 ml warm water for 5 min
arm group label: Group A
intervention type: Other
intervention name: green tea mouthwash
description: , in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
arm group label: Group B
intervention type: Other
intervention name: placebo
description: Plain water
arm group label: Group C
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Taibah University
investigator full name: Alhanouf M. AlRehaili
investigator title: Principal Investigator
mesh term: Gingivitis