<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/NCT02235532</url>
  </required_header>
  <id_info>
    <org_study_id>IRCT2014040517053N2</org_study_id>
    <nct_id>NCT02235532</nct_id>
  </id_info>
  <brief_title>Effects of Aloe Vera Toothpaste on Periodontal Parameters</brief_title>
  <official_title>Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Islamic Azad University, Tehran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Islamic Azad University, Tehran</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and&#xD;
      gingivitis.&#xD;
&#xD;
      The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and&#xD;
      10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided&#xD;
      into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out&#xD;
      period was allowed and then subjects used fluoride toothpaste for the next 30 days . This&#xD;
      order was reversed in group 2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Toothpastes are used with tooth brushing to better control microbial plaque. Herbal&#xD;
      toothpastes have recently gained attention. This study aimed to assess the effects of Aloe&#xD;
      Vera toothpaste on dental plaque and gingivitis.&#xD;
&#xD;
      This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and&#xD;
      10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided&#xD;
      into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque&#xD;
      index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and&#xD;
      then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI&#xD;
      assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated&#xD;
      Measure ANOVA tests were applied for statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">February 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measuring gingival index</measure>
    <time_frame>1-2days</time_frame>
    <description>to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>measuring gingival index</measure>
    <time_frame>1-2 days</time_frame>
    <description>to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>measuring plaque index</measure>
    <time_frame>1-2 days</time_frame>
    <description>to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the plaque index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Foramen Herbal Aloe toothpaste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>use of fluoride toothpaste (signal)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use of a fluoride toothpaste (signal) in control group once a day for 30 days .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Foramen Herbal Aloe toothpaste</intervention_name>
    <description>use of aloe-vera toothpaste for 30 days in the test group.</description>
    <arm_group_label>Foramen Herbal Aloe toothpaste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fluoride toothpaste</intervention_name>
    <description>use of signal toothpaste once a day for 30 days in the control group.</description>
    <arm_group_label>use of fluoride toothpaste (signal)</arm_group_label>
    <other_name>signal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects were selected among dental students with at least 20 natural teeth without&#xD;
             systemic disease&#xD;
&#xD;
          -  No periodontal treatment at least 6 months to the study&#xD;
&#xD;
          -  No use of systemic antibiotic and anti-inflammatory drugs within the last 3 months,&#xD;
             nonsmokers, no pregnancy or lactating women&#xD;
&#xD;
          -  Subjects with PD≤3mm, (clinical attachment level)CAL&lt;1mm, PI≥2 and gingival bleeding&#xD;
             in more than 30% of the tested areas were enrolled with the diagnosis of&#xD;
             plaque-related gingivitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple&#xD;
             caries were excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ferena Sayar, DDS;MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tehran Dental Branch, Islamic Azad University,Tehran/Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tehran Dental Branch, Islamic azad University</name>
      <address>
        <city>Tehran</city>
        <zip>19585175</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>January 13, 2015</last_update_submitted>
  <last_update_submitted_qc>January 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Islamic Azad University, Tehran</investigator_affiliation>
    <investigator_full_name>Ferena Sayar</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>clinical trial</keyword>
  <keyword>oral hygiene</keyword>
  <keyword>Gingivitis</keyword>
  <keyword>Aloevera</keyword>
  <keyword>Toothpaste</keyword>
  <keyword>anti-inflammatory agents</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>Fluorides</mesh_term>
  </intervention_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/NCT02235532
org study id: IRCT2014040517053N2
nct id: NCT02235532
lead sponsor: 
has dmc: No
This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and
      gingivitis.

      The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and
      10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided
      into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out
      period was allowed and then subjects used fluoride toothpaste for the next 30 days . This
      order was reversed in group 2.
Toothpastes are used with tooth brushing to better control microbial plaque. Herbal
      toothpastes have recently gained attention. This study aimed to assess the effects of Aloe
      Vera toothpaste on dental plaque and gingivitis.

      This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and
      10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided
      into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque
      index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and
      then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI
      assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated
      Measure ANOVA tests were applied for statistical analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: measuring gingival index
time frame: 1-2days
description: to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
measure: measuring gingival index
time frame: 1-2 days
description: to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
measure: measuring plaque index
time frame: 1-2 days
description: to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the plaque index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
arm group label: Foramen Herbal Aloe toothpaste
arm group type: Experimental
description: test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day.
arm group label: use of fluoride toothpaste (signal)
arm group type: Active Comparator
description: use of a fluoride toothpaste (signal) in control group once a day for 30 days .
intervention type: Other
intervention name: Foramen Herbal Aloe toothpaste
description: use of aloe-vera toothpaste for 30 days in the test group.
arm group label: Foramen Herbal Aloe toothpaste
intervention type: Other
intervention name: fluoride toothpaste
description: use of signal toothpaste once a day for 30 days in the control group.
arm group label: use of fluoride toothpaste (signal)
other name: signal
criteria: 
gender: All
minimum age: 20 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ferena Sayar, DDS;MSc
role: Principal Investigator
affiliation: Tehran Dental Branch, Islamic Azad University,Tehran/Iran
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Islamic Azad University, Tehran
investigator full name: Ferena Sayar
investigator title: assistant professor
mesh term: Gingivitis
mesh term: Fluorides