xml: <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/NCT06013735</url>
    </required_header>
    <id_info>
      <org_study_id>241/2019</org_study_id>
      <nct_id>NCT06013735</nct_id>
    </id_info>
    <brief_title>Effects of Three Different Mouth Rinses on Dental Plaque in Children</brief_title>
    <official_title>Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suez Canal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suez Canal 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>
        Dental plaque is a major problem in the field of oral and dental health and its prevention is&#xD;
        more important to avoid dental caries and gingival diseases. Mouth washes are very useful in&#xD;
        the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is&#xD;
        one of the ways that prevent dental plaque. Recently, using herbal products are efficient in&#xD;
        decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential&#xD;
        medicinal plant with various pharmacological properties.&#xD;
  &#xD;
        Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium&#xD;
        fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental&#xD;
        plaque in children, clinically by measuring gingival and plaque indices scores and&#xD;
        microbiologically by measuring of streptococcus mutans and lactobacillus.&#xD;
  &#xD;
        Materials and methods: forty apparently healthy and cooperative children were selected from&#xD;
        the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez&#xD;
        Canal University. Children were randomly divided into three groups as follows:&#xD;
  &#xD;
        Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse&#xD;
        with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate&#xD;
        peels aqueous extract. Group (IV):10 children will rinse with water (control group).&#xD;
        Instructions for oral hygiene and using mouth wash will be demonstrated for every child.&#xD;
        Clinical and microbiological examinations will be done firstly at day one before using any&#xD;
        type of examined mouthwashes (0-base line), then clinical and microbiological follow up will&#xD;
        be done after 7 and 15 days of using different mouthwash for each group.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 17, 2020</start_date>
    <completion_date type="Actual">June 22, 2021</completion_date>
    <primary_completion_date type="Actual">June 15, 2021</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>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gingival health</measure>
      <time_frame>baseline , after 7 days and after 15 days</time_frame>
      <description>gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>plaque accumulation and pocket depth</measure>
      <time_frame>baseline , after 7 days and after 15 days</time_frame>
      <description>plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket</description>
    </primary_outcome>
    <primary_outcome>
      <measure>streptococcus mutans and lactobacilli count</measure>
      <time_frame>baseline , after 7 days and after 15 days</time_frame>
      <description>calculate the counts of streptococcus mutans and lactobacilli</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Gingival Diseases</condition>
    <arm_group>
      <arm_group_label>sodium fluoride solution</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>children will rinse with sodium fluoride solution mouth rinse (0.2%).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>guava leaves</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>children will rinse with guava leaves aqueous extract mouth rinse (0.5%).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>pomegranate peel</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>children will rinse with distilled water</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>sodium fluoride solution</intervention_name>
      <description>sodium fluoride solution mouth rinse (0.2%).</description>
      <arm_group_label>sodium fluoride solution</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>guava leaves aqueous extract</intervention_name>
      <description>guava leaves aqueous extract mouth rinse (0.5%)</description>
      <arm_group_label>guava leaves</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pomegranate peel aqueous extrac</intervention_name>
      <description>pomegranate peel aqueous extract mouth rinse (0.5%).</description>
      <arm_group_label>pomegranate peel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Distilled water</intervention_name>
      <description>placebo distilled water</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Children are apparently healthy.&#xD;
  &#xD;
            2. Their age's ranges from 6-12 years {mixed dentition}, First permanent molars were&#xD;
               fully erupted.&#xD;
  &#xD;
            3. Children are not taking antibiotics, steroids and inflammatory therapy for two weeks&#xD;
               before study or during this study.&#xD;
  &#xD;
            4. Children are caries free at time of the study.&#xD;
  &#xD;
            5. Children with no regular use of chewing xylitol gum.&#xD;
  &#xD;
            6. Children without orthodontic appliance.&#xD;
  &#xD;
            7. Children are not using fluoride tooth paste or any topical fluoride application at&#xD;
               time of study.&#xD;
  &#xD;
            8. Children who have dental plaque.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Uncooperative children.&#xD;
  &#xD;
            2. Children with history of allergy to dental products or their products&#xD;
  &#xD;
            3. Parents refusal.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>faculty of dentistry Suez canal university</name>
        <address>
          <city>Ismailia</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2021</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Plaque</mesh_term>
      <mesh_term>Gingival Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Listerine</mesh_term>
      <mesh_term>Fluorides</mesh_term>
      <mesh_term>Sodium Fluoride</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013735
  org study id: 241/2019
  nct id: NCT06013735
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dental plaque is a major problem in the field of oral and dental health and its prevention is
        more important to avoid dental caries and gingival diseases. Mouth washes are very useful in
        the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is
        one of the ways that prevent dental plaque. Recently, using herbal products are efficient in
        decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential
        medicinal plant with various pharmacological properties.
  
        Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium
        fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental
        plaque in children, clinically by measuring gingival and plaque indices scores and
        microbiologically by measuring of streptococcus mutans and lactobacillus.
  
        Materials and methods: forty apparently healthy and cooperative children were selected from
        the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez
        Canal University. Children were randomly divided into three groups as follows:
  
        Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse
        with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate
        peels aqueous extract. Group (IV):10 children will rinse with water (control group).
        Instructions for oral hygiene and using mouth wash will be demonstrated for every child.
        Clinical and microbiological examinations will be done firstly at day one before using any
        type of examined mouthwashes (0-base line), then clinical and microbiological follow up will
        be done after 7 and 15 days of using different mouthwash for each group.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: Gingival health
  time frame: baseline , after 7 days and after 15 days
  description: gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation
  measure: plaque accumulation and pocket depth
  time frame: baseline , after 7 days and after 15 days
  description: plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket
  measure: streptococcus mutans and lactobacilli count
  time frame: baseline , after 7 days and after 15 days
  description: calculate the counts of streptococcus mutans and lactobacilli
  arm group label: sodium fluoride solution
  arm group type: Active Comparator
  description: children will rinse with sodium fluoride solution mouth rinse (0.2%).
  arm group label: guava leaves
  arm group type: Active Comparator
  description: children will rinse with guava leaves aqueous extract mouth rinse (0.5%).
  arm group label: pomegranate peel
  arm group type: Active Comparator
  description: children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%).
  arm group label: Control
  arm group type: Placebo Comparator
  description: children will rinse with distilled water
  intervention type: Drug
  intervention name: sodium fluoride solution
  description: sodium fluoride solution mouth rinse (0.2%).
  arm group label: sodium fluoride solution
  intervention type: Drug
  intervention name: guava leaves aqueous extract
  description: guava leaves aqueous extract mouth rinse (0.5%)
  arm group label: guava leaves
  intervention type: Drug
  intervention name: pomegranate peel aqueous extrac
  description: pomegranate peel aqueous extract mouth rinse (0.5%).
  arm group label: pomegranate peel
  intervention type: Other
  intervention name: Distilled water
  description: placebo distilled water
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Dental Plaque
  mesh term: Gingival Diseases
  mesh term: Listerine
  mesh term: Fluorides
  mesh term: Sodium Fluoride