<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/NCT02227485</url>
  </required_header>
  <id_info>
    <org_study_id>CT93747064</org_study_id>
    <nct_id>NCT02227485</nct_id>
  </id_info>
  <brief_title>Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients</brief_title>
  <acronym>Golnaar</acronym>
  <official_title>Evaluation of the Effects of an Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Patients With Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shiraz University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian&#xD;
      traditional mouth rinse (Punica granatum Pleniflora or &quot;Golnaar&quot; mouthrinse) on treatment of&#xD;
      diabetic gingivitis and compare it with chlorhexidine (0.2%).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical&#xD;
      Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill&#xD;
      other inclusion criteria, are randomly assigned to intervention or control groups. All of the&#xD;
      patients will undergo a training panel about mouth hygiene and receive a pack of a&#xD;
      toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2&#xD;
      weeks for the second evaluation and taking tooth bleaching. The demographic and general&#xD;
      information of all participants are taken and the primary outputs (plaque index and bleeding&#xD;
      on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the&#xD;
      examinations are done by one trained person and patients, practitioner and statistical&#xD;
      analyser are blind to the interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plaque Index</measure>
    <time_frame>At the beginning, after 2 weeks and after 4 weeks</time_frame>
    <description>0 No plaque&#xD;
A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.&#xD;
Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.&#xD;
Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding Index</measure>
    <time_frame>At the beginning, after 2 weeks and after 4 weeks.</time_frame>
    <description>presence of bleeding of the gum when probing it: 0= No bleeding&#xD;
1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pocket Depth</measure>
    <time_frame>At the beginning, after 2 weeks and after 4 weeks</time_frame>
    <description>It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Gingival Index</measure>
    <time_frame>At the beginning, after 2 weeks and after 4 weeks.</time_frame>
    <description>0= Absence of inflammation&#xD;
Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary&#xD;
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary&#xD;
moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary&#xD;
severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of Patients</measure>
    <time_frame>Up to 2 week</time_frame>
    <description>We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.&#xD;
This &quot;VAS&quot; ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:&#xD;
Not satisfied at all&#xD;
Not satisfied adequately&#xD;
Not good-Not bad (So So)&#xD;
Mostly Satisfied&#xD;
Fully satisfied</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine (0.2%)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Punica granatum Pleniflora mouth rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Punica granatum Pleniflora (Golnaar) mouth rinse</intervention_name>
    <description>All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.</description>
    <arm_group_label>Punica granatum Pleniflora mouth rinse</arm_group_label>
    <other_name>Intervention group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine (0.2%)</intervention_name>
    <description>All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.</description>
    <arm_group_label>Chlorhexidine (0.2%)</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tooth bleaching</intervention_name>
    <description>Tooth bleaching for both groups one time after using mouth rinses.</description>
    <arm_group_label>Chlorhexidine (0.2%)</arm_group_label>
    <arm_group_label>Punica granatum Pleniflora mouth rinse</arm_group_label>
    <other_name>Bleaching</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have gingivitis&#xD;
&#xD;
          -  Controlled diabetes mellitus [FBS&lt;130mg/dl &amp; Glycosilated hemoglobin (A1C)&lt;7%]&#xD;
&#xD;
          -  Presence of gingivitis&#xD;
&#xD;
          -  Having at least 20 teeth&#xD;
&#xD;
          -  No history of hypersensitivity reaction&#xD;
&#xD;
          -  Age between 20 to 65 years&#xD;
&#xD;
          -  Agreement to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity reaction&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Systemic diseases (Kidney, liver or rheumatologic diseases)&#xD;
&#xD;
          -  To have a pocket depth of more than 5&#xD;
&#xD;
          -  Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in&#xD;
             the past 3 months and during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mesbah Shams, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Research Center for Traditional Medicine &amp; History of Medicine - Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammad Mahdi Fani, Dentist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center for Traditional Medicine &amp; History of Medicine-Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Massih Seddigh-Rahimabadi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Motahhari clinic of Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <state>Fars</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>December 26, 2014</results_first_submitted>
  <results_first_submitted_qc>July 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 24, 2016</results_first_posted>
  <last_update_submitted>July 13, 2016</last_update_submitted>
  <last_update_submitted_qc>July 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mesbah Shams, MD</investigator_full_name>
    <investigator_title>Associate professor of Internal Medicine &amp; Endocrinology</investigator_title>
  </responsible_party>
  <keyword>Gingivitis</keyword>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Medicine, Traditional</keyword>
  <keyword>Herbal medicine</keyword>
  <keyword>Punica granatum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the records have been collected and archived, and can be reused if is necessary.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment for Chlorhexidine group started on 11/05/2014 and ended on 07/11/2014. For Golnaar group the starting and ending dates were; 01/05/2014 and 09/11/2014.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Chlorhexidine (0.2%)</title>
          <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
        </group>
        <group group_id="P2">
          <title>Punica Granatum Pleniflora Mouth Rinse</title>
          <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36">At the first follow-up we lost 4 patients.</participants>
                <participants group_id="P2" count="38">After 2 weeks, 2 patients had withdrew the study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34">At the second follow-up we lost 2 patients.</participants>
                <participants group_id="P2" count="36">At the second follow-up we lost 2 patients.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chlorhexidine (0.2%)</title>
          <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
        </group>
        <group group_id="B2">
          <title>Punica Granatum Pleniflora Mouth Rinse</title>
          <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.3" spread="6.5"/>
                    <measurement group_id="B2" value="50.35" spread="6.9"/>
                    <measurement group_id="B3" value="51.33" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Iran, Islamic Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <description>The height of patients in centimeter (cm)</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.9" spread="9.6"/>
                    <measurement group_id="B2" value="164.1" spread="10.0"/>
                    <measurement group_id="B3" value="164" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.1" spread="13.5"/>
                    <measurement group_id="B2" value="75.6" spread="13.8"/>
                    <measurement group_id="B3" value="75.4" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.3" spread="6.2"/>
                    <measurement group_id="B2" value="9.7" spread="6.3"/>
                    <measurement group_id="B3" value="10" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Teeth number</title>
          <units>teeth</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.7" spread="3.3"/>
                    <measurement group_id="B2" value="25.0" spread="3.6"/>
                    <measurement group_id="B3" value="24.9" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BP</title>
          <description>The maximum arterial blood pressure</description>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.3" spread="1"/>
                    <measurement group_id="B2" value="12.5" spread="1.2"/>
                    <measurement group_id="B3" value="12.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Plaque Index</title>
        <description>0 No plaque&#xD;
A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.&#xD;
Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.&#xD;
Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.</description>
        <time_frame>At the beginning, after 2 weeks and after 4 weeks</time_frame>
        <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine (0.2%)</title>
            <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
          <group group_id="O2">
            <title>Punica Granatum Pleniflora Mouth Rinse</title>
            <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
        </group_list>
        <measure>
          <title>Plaque Index</title>
          <description>0 No plaque&#xD;
A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.&#xD;
Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.&#xD;
Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.</description>
          <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At base line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.9"/>
                    <measurement group_id="O2" value="2.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1"/>
                    <measurement group_id="O2" value="2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.2"/>
                    <measurement group_id="O2" value="0.2" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bleeding Index</title>
        <description>presence of bleeding of the gum when probing it: 0= No bleeding&#xD;
1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice</description>
        <time_frame>At the beginning, after 2 weeks and after 4 weeks.</time_frame>
        <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine (0.2%)</title>
            <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
          <group group_id="O2">
            <title>Punica Granatum Pleniflora Mouth Rinse</title>
            <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding Index</title>
          <description>presence of bleeding of the gum when probing it: 0= No bleeding&#xD;
1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice</description>
          <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At base line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.133" spread="0.097"/>
                    <measurement group_id="O2" value="0.148" spread="0.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.039" spread="0.057"/>
                    <measurement group_id="O2" value="0.034" spread="0.056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.034"/>
                    <measurement group_id="O2" value="0.016" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <time_frame>Up to 2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine (0.2%)</title>
            <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
          <group group_id="O2">
            <title>Punica Granatum Pleniflora Mouth Rinse</title>
            <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had some adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction of Patients</title>
        <description>We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.&#xD;
This &quot;VAS&quot; ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:&#xD;
Not satisfied at all&#xD;
Not satisfied adequately&#xD;
Not good-Not bad (So So)&#xD;
Mostly Satisfied&#xD;
Fully satisfied</description>
        <time_frame>Up to 2 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine (0.2%)</title>
            <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
          <group group_id="O2">
            <title>Punica Granatum Pleniflora Mouth Rinse</title>
            <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction of Patients</title>
          <description>We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.&#xD;
This &quot;VAS&quot; ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:&#xD;
Not satisfied at all&#xD;
Not satisfied adequately&#xD;
Not good-Not bad (So So)&#xD;
Mostly Satisfied&#xD;
Fully satisfied</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>So-So</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pocket Depth</title>
        <description>It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).</description>
        <time_frame>At the beginning, after 2 weeks and after 4 weeks</time_frame>
        <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine (0.2%)</title>
            <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
          <group group_id="O2">
            <title>Punica Granatum Pleniflora Mouth Rinse</title>
            <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
        </group_list>
        <measure>
          <title>Pocket Depth</title>
          <description>It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).</description>
          <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At base line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.8"/>
                    <measurement group_id="O2" value="1.6" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.7"/>
                    <measurement group_id="O2" value="0.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.6"/>
                    <measurement group_id="O2" value="0.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Modified Gingival Index</title>
        <description>0= Absence of inflammation&#xD;
Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary&#xD;
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary&#xD;
moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary&#xD;
severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration</description>
        <time_frame>At the beginning, after 2 weeks and after 4 weeks.</time_frame>
        <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
        <group_list>
          <group group_id="O1">
            <title>Chlorhexidine (0.2%)</title>
            <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
          <group group_id="O2">
            <title>Punica Granatum Pleniflora Mouth Rinse</title>
            <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Gingival Index</title>
          <description>0= Absence of inflammation&#xD;
Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary&#xD;
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary&#xD;
moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary&#xD;
severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration</description>
          <population>The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At base line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1"/>
                    <measurement group_id="O2" value="1.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.6"/>
                    <measurement group_id="O2" value="0.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.3"/>
                    <measurement group_id="O2" value="0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the study and up to 1 month after finishing mouth rinses.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Chlorhexidine (0.2%)</title>
          <description>Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
        </group>
        <group group_id="E2">
          <title>Punica Granatum Pleniflora Mouth Rinse</title>
          <description>Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.&#xD;
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of &quot;Golnaar&quot; mouth rinse for 2 minutes every night for 2 weeks.&#xD;
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Unpleasant taste</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="36"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Other side effects</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Discolored</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Bad Odor</sub_title>
                <description>Bad odor of the mouth wash</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Mahsa Rostami-Chijan</name_or_title>
      <organization>Shiraz University of Medical Sciences</organization>
      <phone>+989111960300</phone>
      <email>mahsa_59_2007@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02227485
org study id: CT93747064
nct id: NCT02227485
lead sponsor: 
has dmc: Yes
This is a triple-blinded randomized clinical trial to evaluate the effect of an Iranian
      traditional mouth rinse (Punica granatum Pleniflora or "Golnaar" mouthrinse) on treatment of
      diabetic gingivitis and compare it with chlorhexidine (0.2%).
Among diabetic patients who refer to Motahhari clinic of Shiraz University of Medical
      Sciences 80 volunteers who have gingivitis and aged between 20 to 65 years old and fulfill
      other inclusion criteria, are randomly assigned to intervention or control groups. All of the
      patients will undergo a training panel about mouth hygiene and receive a pack of a
      toothbrush, a toothpaste, a dental floss and a mouth rinse. They are asked to return after 2
      weeks for the second evaluation and taking tooth bleaching. The demographic and general
      information of all participants are taken and the primary outputs (plaque index and bleeding
      on probe) are measured at the beginning, after 2 weeks and after 4 weeks. All the
      examinations are done by one trained person and patients, practitioner and statistical
      analyser are blind to the interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Plaque Index
time frame: At the beginning, after 2 weeks and after 4 weeks
description: 0 No plaque
A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.
Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
measure: Bleeding Index
time frame: At the beginning, after 2 weeks and after 4 weeks.
description: presence of bleeding of the gum when probing it: 0= No bleeding
1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice
measure: Pocket Depth
time frame: At the beginning, after 2 weeks and after 4 weeks
description: It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).
measure: Modified Gingival Index
time frame: At the beginning, after 2 weeks and after 4 weeks.
description: 0= Absence of inflammation
Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary
Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary
moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary
severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration
measure: Number of Participants With Adverse Events
time frame: Up to 2 weeks
measure: Satisfaction of Patients
time frame: Up to 2 week
description: We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.
This "VAS" ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:
Not satisfied at all
Not satisfied adequately
Not good-Not bad (So So)
Mostly Satisfied
Fully satisfied
arm group label: Chlorhexidine (0.2%)
arm group type: Active Comparator
description: Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
arm group label: Punica granatum Pleniflora mouth rinse
arm group type: Experimental
description: Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
intervention type: Drug
intervention name: Punica granatum Pleniflora (Golnaar) mouth rinse
description: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
arm group label: Punica granatum Pleniflora mouth rinse
other name: Intervention group
intervention type: Drug
intervention name: Chlorhexidine (0.2%)
description: All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
arm group label: Chlorhexidine (0.2%)
other name: Control group
intervention type: Procedure
intervention name: Tooth bleaching
description: Tooth bleaching for both groups one time after using mouth rinses.
arm group label: Chlorhexidine (0.2%)
arm group label: Punica granatum Pleniflora mouth rinse
other name: Bleaching
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mesbah Shams, MD
role: Study Chair
affiliation: Research Center for Traditional Medicine & History of Medicine - Shiraz University of Medical Sciences
last name: Mohammad Mahdi Fani, Dentist
role: Principal Investigator
affiliation: Research Center for Traditional Medicine & History of Medicine-Shiraz University of Medical Sciences
last name: Massih Seddigh-Rahimabadi, MD
role: Principal Investigator
affiliation: Shiraz University of Medical Sciences
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Mesbah Shams, MD
investigator title: Associate professor of Internal Medicine & Endocrinology
mesh term: Gingivitis
mesh term: Chlorhexidine
sharing ipd: Yes
ipd description: All the records have been collected and archived, and can be reused if is necessary.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size
point of contact: 