<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/NCT02989233</url>
  </required_header>
  <id_info>
    <org_study_id>36290600/93</org_study_id>
    <nct_id>NCT02989233</nct_id>
  </id_info>
  <brief_title>Impact of Three Different Education Methods on Oral Hygiene</brief_title>
  <official_title>Impact of Three Different Education Methods on Oral Hygiene and Theoretical Knowledge of Schoolchildren</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umut BALLI</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bulent Ecevit University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13,&#xD;
      were divided into 12 equal experimental groups according to their ages and gender. They were&#xD;
      all considered to have poor hygiene. Only one out of the three different education methods&#xD;
      (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP&#xD;
      and theoretical test points from the baseline to the 6th months were evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: The aim the present study was to evaluate the impact of three different education&#xD;
      methods on the oral hygiene levels of school children using clinical and theoretical&#xD;
      findings.&#xD;
&#xD;
      Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged&#xD;
      between 8-13, were divided into 12 equal experimental groups according to their ages and&#xD;
      gender. They were all considered to have poor hygiene. Only one out of the three different&#xD;
      education methods (brochure, model or video) was applied to each group. The percentage change&#xD;
      in PI, GI, BOP and theoretical test points from the baseline to the 6th months were&#xD;
      evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA&#xD;
      tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Theoretical Test Application</measure>
    <time_frame>Baseline and 6 months after treatment</time_frame>
    <description>The changes in theoretical test scores after education</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival index</measure>
    <time_frame>Baseline and 6 months after treatment</time_frame>
    <description>The changes in gingival index after education</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>Baseline and 6 months after treatment</time_frame>
    <description>The changes in plaque index after education</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>Baseline and 6 months after treatment</time_frame>
    <description>The changes in bleeding on probing after education</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Oral Hygiene</condition>
  <arm_group>
    <arm_group_label>Brochure-Female-8/10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Female 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brochure-Male-8/10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model-Female-8/10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Female 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model-Male-8/10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video-Female-8/10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Female 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video-Male-8/10</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brochure-Female-11/13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Female 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brochure-Male-11/13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model-Female-11/13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Female 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model-Male-11/13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video-Female-11/13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Female 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video-Male-11/13</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-surgical periodontal treatment</intervention_name>
    <description>Scaling and oral hygiene instructions with brochure, model or video</description>
    <arm_group_label>Brochure-Female-11/13</arm_group_label>
    <arm_group_label>Brochure-Female-8/10</arm_group_label>
    <arm_group_label>Brochure-Male-11/13</arm_group_label>
    <arm_group_label>Brochure-Male-8/10</arm_group_label>
    <arm_group_label>Model-Female-11/13</arm_group_label>
    <arm_group_label>Model-Female-8/10</arm_group_label>
    <arm_group_label>Model-Male-11/13</arm_group_label>
    <arm_group_label>Model-Male-8/10</arm_group_label>
    <arm_group_label>Video-Female-11/13</arm_group_label>
    <arm_group_label>Video-Female-8/10</arm_group_label>
    <arm_group_label>Video-Male-11/13</arm_group_label>
    <arm_group_label>Video-Male-8/10</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  According to the Simplified Oral Hygiene Index, the patients having the score of 2 and&#xD;
             over were accepted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  According to the Simplified Oral Hygiene Index, the patients having the score under 2&#xD;
             were not included in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bulent Ecevit University</investigator_affiliation>
    <investigator_full_name>Umut BALLI</investigator_full_name>
    <investigator_title>Faculty of Dentistry</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02989233
org study id: 36290600/93
nct id: NCT02989233
lead sponsor: 
has dmc: No
In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13,
      were divided into 12 equal experimental groups according to their ages and gender. They were
      all considered to have poor hygiene. Only one out of the three different education methods
      (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP
      and theoretical test points from the baseline to the 6th months were evaluated.
Aim: The aim the present study was to evaluate the impact of three different education
      methods on the oral hygiene levels of school children using clinical and theoretical
      findings.

      Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged
      between 8-13, were divided into 12 equal experimental groups according to their ages and
      gender. They were all considered to have poor hygiene. Only one out of the three different
      education methods (brochure, model or video) was applied to each group. The percentage change
      in PI, GI, BOP and theoretical test points from the baseline to the 6th months were
      evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA
      tests.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Theoretical Test Application
time frame: Baseline and 6 months after treatment
description: The changes in theoretical test scores after education
measure: Gingival index
time frame: Baseline and 6 months after treatment
description: The changes in gingival index after education
measure: Plaque index
time frame: Baseline and 6 months after treatment
description: The changes in plaque index after education
measure: Bleeding on probing
time frame: Baseline and 6 months after treatment
description: The changes in bleeding on probing after education
arm group label: Brochure-Female-8/10
arm group type: Active Comparator
description: Female 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Brochure-Male-8/10
arm group type: Active Comparator
description: Male 8-10 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Model-Female-8/10
arm group type: Active Comparator
description: Female 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Model-Male-8/10
arm group type: Active Comparator
description: Male 8-10 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Video-Female-8/10
arm group type: Active Comparator
description: Female 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Video-Male-8/10
arm group type: Active Comparator
description: Male 8-10 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Brochure-Female-11/13
arm group type: Active Comparator
description: Female 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Brochure-Male-11/13
arm group type: Active Comparator
description: Male 11-13 years Theoretical Test Application Giving a brochure Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Model-Female-11/13
arm group type: Active Comparator
description: Female 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Model-Male-11/13
arm group type: Active Comparator
description: Male 11-13 years Theoretical Test Application Expression with a model Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Video-Female-11/13
arm group type: Active Comparator
description: Female 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
arm group label: Video-Male-11/13
arm group type: Active Comparator
description: Male 11-13 years Theoretical Test Application Showing a video Bleeding on probing, plaque index and gingival index Non-surgical periodontal treatment
intervention type: Other
intervention name: Non-surgical periodontal treatment
description: Scaling and oral hygiene instructions with brochure, model or video
arm group label: Brochure-Female-11/13
arm group label: Brochure-Female-8/10
arm group label: Brochure-Male-11/13
arm group label: Brochure-Male-8/10
arm group label: Model-Female-11/13
arm group label: Model-Female-8/10
arm group label: Model-Male-11/13
arm group label: Model-Male-8/10
arm group label: Video-Female-11/13
arm group label: Video-Female-8/10
arm group label: Video-Male-11/13
arm group label: Video-Male-8/10
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Bulent Ecevit University
investigator full name: Umut BALLI
investigator title: Faculty of Dentistry
sharing ipd: No