<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/NCT03790904</url>
  </required_header>
  <id_info>
    <org_study_id>011618</org_study_id>
    <nct_id>NCT03790904</nct_id>
  </id_info>
  <brief_title>Anti Plaque Efficacy of Salvadora Persica L. and Green Tea Mouthwash</brief_title>
  <official_title>Evaluation of Anti-plaque Effect of a Mouthwash Composed of Salvadora Persica L. and Green Tea: a 4days Randomized Controlled Crossover Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Baghdad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Baghdad</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>
      Periodontal diseases and caries are essentially initiated and progressed by accumulation of&#xD;
      dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and&#xD;
      maintaining oral health. Mechanical plaque control is important but has limitations;&#xD;
      therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various&#xD;
      medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic&#xD;
      mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green&#xD;
      tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours.&#xD;
      Moreover, these extracts were reported to have anti-microbial activity against many oral&#xD;
      bacteria. The objective of this study was to investigate the efficacy of the combination of&#xD;
      Gt aqueous extract and Sp aqueous extract in reducing plaque buildup for 4 days duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental plaque is the soft mass formed on oral surfaces including tooth surfaces. It composed&#xD;
      of many species of which are commensal and other are pathogenic. The buildup of dental plaque&#xD;
      starts by adhesion of floating bacteria, primary colonizers, in saliva onto oral surfaces&#xD;
      such as tooth surfaces. Consequently, after adhesion, these primary bacteria provide adhesion&#xD;
      sites for secondary plaque colonizers and the plaque buildup continues to achieve a mature&#xD;
      dental plaque.&#xD;
&#xD;
      The mature dental plaque initiates host immune response by its bacterial content or its&#xD;
      toxins in the adjacent gingival tissues. Periodontal health is assumed to be in a state of&#xD;
      balance when the host immune response resolves the bacterial challenges. In other scenario,&#xD;
      the host immune response fails to overcome invader bacteria or their toxins leading to&#xD;
      chronicity of aberrant immune responses. Thus, periodontal diseases and caries may be&#xD;
      developed due to imbalance between dental plaque accumulation and host defense. For that&#xD;
      reason, dental plaque control is essential as preventive measure for good oral health.&#xD;
&#xD;
      Mechanical plaque control including tooth brushing and interdental aids is essential for&#xD;
      preserving oral health. However, efficient mechanical control is time consuming and needs&#xD;
      high manual dexterity and compliance. Therefore, chemical plaque control such as mouthwashes&#xD;
      might be useful as adjunctive to mechanical control. Chlorohexidine mouthwash is the&#xD;
      best-known mouthwash serving that purpose despite its side effects including tooth&#xD;
      discoloration and bitter taste.&#xD;
&#xD;
      Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis, aqueous&#xD;
      extracts were reported to exert anti-microbial activity against many oral bacteria. A&#xD;
      combination (Co.) of Gt aqueous extract and Sp aqueous extract at a specific concentration&#xD;
      (patented, IP 2015704777) was found to exhibit significant synergistic anti-bacterial and&#xD;
      anti-adherence efficacy against primary plaque colonizers in vitro. This Co. as a mouthwash&#xD;
      was reported to significantly reduce plaque accumulation comparing to chlorhexidine in vivo&#xD;
      for a period of 24 hours (NCT02624336 in December 3, 2015).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">April 9, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean amount plaque between different comparators</measure>
    <time_frame>Time Frame: 24 hours</time_frame>
    <description>Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean amount plaque between different comparators</measure>
    <time_frame>Time Frame: 4 days</time_frame>
    <description>Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean bacterial load in saliva</measure>
    <time_frame>2 hours</time_frame>
    <description>Mean bacterial load in saliva at 2 hours after rinsing with different comparators using quantitative polymerase chain reaction (qPCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean relative changes in gingival crevicular fluid flow rate</measure>
    <time_frame>4 days</time_frame>
    <description>Mean relative changes in gingival crevicular fluid flow rate after rinsing with different comparators from baseline at 4 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid</measure>
    <time_frame>4 days</time_frame>
    <description>Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid after rinsing with different comparators from baseline at 4 days.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Co. mouthwash</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kin mouthwash</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distilled water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Co.</intervention_name>
    <description>15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min</description>
    <arm_group_label>Co. mouthwash</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kin</intervention_name>
    <description>15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min</description>
    <arm_group_label>Kin mouthwash</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Distilled water</intervention_name>
    <description>15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min</description>
    <arm_group_label>Distilled water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants should be medically healthy.&#xD;
&#xD;
          -  Participants should have more than 20 teeth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have active cavity caries and/or periodontal disease.&#xD;
&#xD;
          -  Participants who have ongoing orthodontic treatment.&#xD;
&#xD;
          -  Participants who have been on antibiotics within the past 4 months.&#xD;
&#xD;
          -  Participants who require prophylactic antibiotic coverage.&#xD;
&#xD;
          -  Participants who have been on systemic or topical non-steroidal anti-inflammatory&#xD;
             drugs for the past 4 months.&#xD;
&#xD;
          -  Participants who are pregnant or intended to and lactating mother.&#xD;
&#xD;
          -  Participants who have heart valve replacement and have known intolerance or allergy to&#xD;
             mouth rinses.&#xD;
&#xD;
          -  Participants who have any systemic disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rasha S Abbood</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Baghdad</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hayder R Abdulbaqi</name>
      <address>
        <city>Baghdad</city>
        <zip>10011</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>May 11, 2019</last_update_submitted>
  <last_update_submitted_qc>May 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Baghdad</investigator_affiliation>
    <investigator_full_name>Hayder Raad Abdulbaqi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dental plaque,</keyword>
  <keyword>Tea</keyword>
  <keyword>Salvadora</keyword>
  <keyword>Mouthwash</keyword>
  <keyword>Clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03790904
org study id: 011618
nct id: NCT03790904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Periodontal diseases and caries are essentially initiated and progressed by accumulation of
      dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and
      maintaining oral health. Mechanical plaque control is important but has limitations;
      therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various
      medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic
      mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green
      tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours.
      Moreover, these extracts were reported to have anti-microbial activity against many oral
      bacteria. The objective of this study was to investigate the efficacy of the combination of
      Gt aqueous extract and Sp aqueous extract in reducing plaque buildup for 4 days duration.
Dental plaque is the soft mass formed on oral surfaces including tooth surfaces. It composed
      of many species of which are commensal and other are pathogenic. The buildup of dental plaque
      starts by adhesion of floating bacteria, primary colonizers, in saliva onto oral surfaces
      such as tooth surfaces. Consequently, after adhesion, these primary bacteria provide adhesion
      sites for secondary plaque colonizers and the plaque buildup continues to achieve a mature
      dental plaque.

      The mature dental plaque initiates host immune response by its bacterial content or its
      toxins in the adjacent gingival tissues. Periodontal health is assumed to be in a state of
      balance when the host immune response resolves the bacterial challenges. In other scenario,
      the host immune response fails to overcome invader bacteria or their toxins leading to
      chronicity of aberrant immune responses. Thus, periodontal diseases and caries may be
      developed due to imbalance between dental plaque accumulation and host defense. For that
      reason, dental plaque control is essential as preventive measure for good oral health.

      Mechanical plaque control including tooth brushing and interdental aids is essential for
      preserving oral health. However, efficient mechanical control is time consuming and needs
      high manual dexterity and compliance. Therefore, chemical plaque control such as mouthwashes
      might be useful as adjunctive to mechanical control. Chlorohexidine mouthwash is the
      best-known mouthwash serving that purpose despite its side effects including tooth
      discoloration and bitter taste.

      Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis, aqueous
      extracts were reported to exert anti-microbial activity against many oral bacteria. A
      combination (Co.) of Gt aqueous extract and Sp aqueous extract at a specific concentration
      (patented, IP 2015704777) was found to exhibit significant synergistic anti-bacterial and
      anti-adherence efficacy against primary plaque colonizers in vitro. This Co. as a mouthwash
      was reported to significantly reduce plaque accumulation comparing to chlorhexidine in vivo
      for a period of 24 hours (NCT02624336 in December 3, 2015).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean amount plaque between different comparators
time frame: Time Frame: 24 hours
description: Mean amount plaque between different comparators as anti-plaque agent following 24 hrs plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
measure: Mean amount plaque between different comparators
time frame: Time Frame: 4 days
description: Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index [Turesky, 1970] and digital plaque image analysis.
measure: Mean bacterial load in saliva
time frame: 2 hours
description: Mean bacterial load in saliva at 2 hours after rinsing with different comparators using quantitative polymerase chain reaction (qPCR).
measure: Mean relative changes in gingival crevicular fluid flow rate
time frame: 4 days
description: Mean relative changes in gingival crevicular fluid flow rate after rinsing with different comparators from baseline at 4 days.
measure: Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid
time frame: 4 days
description: Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid after rinsing with different comparators from baseline at 4 days.
arm group label: Co. mouthwash
arm group type: Active Comparator
description: 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
arm group label: Kin mouthwash
arm group type: Placebo Comparator
description: 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
arm group label: Distilled water
arm group type: Placebo Comparator
description: 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
intervention type: Other
intervention name: Co.
description: 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
arm group label: Co. mouthwash
intervention type: Other
intervention name: Kin
description: 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
arm group label: Kin mouthwash
intervention type: Other
intervention name: Distilled water
description: 15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
arm group label: Distilled water
criteria: 
gender: All
minimum age: 20 Years
maximum age: 23 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rasha S Abbood
role: Principal Investigator
affiliation: University of Baghdad
facility: 
country: Iraq
responsible party type: Principal Investigator
investigator affiliation: University of Baghdad
investigator full name: Hayder Raad Abdulbaqi
investigator title: Principal Investigator
mesh term: Periodontal Diseases
sharing ipd: Undecided