<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/NCT03782311</url>
  </required_header>
  <id_info>
    <org_study_id>c37taicm</org_study_id>
    <nct_id>NCT03782311</nct_id>
  </id_info>
  <brief_title>Oral Hygiene Related Self-efficacy, General Self-efficacy and Daily Plaque Control</brief_title>
  <official_title>The Relationship Between Oral Hygiene Related Self-efficacy, General Self-efficacy and Daily Plaque Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</source>
  <brief_summary>
    <textblock>
      The objectives are a) to determine the scores of general self-efficacy (GSE) and oral hygiene&#xD;
      related self-efficacy (OHSE) b) to evaluate the relations between the scores of GSE and OHSE&#xD;
      c) to examine the changes in OHSE scores and the relationship between OHSE and PI scores&#xD;
      after motivation and oral hygiene instructions. OHSE scores could be an indicator in&#xD;
      predicting daily plaque control of patients. Also, it may be needed to show greater interest&#xD;
      about motivation and oral hygiene instructions especially for smokers and OHSE-low group&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All study patients (n=210) between the ages of 35 to 60 with inflammatory periodontal&#xD;
      diseases filled out questionnaires regarding GSE and OHSE. Subgroups including OHSE-low&#xD;
      (n=26) and OHSE-high (n=26) groups were selected after performing &quot;cut off&quot; on OHSE scores of&#xD;
      all study patients. In both subgroups, plaque index (PI) values were determined, and&#xD;
      motivation and oral hygiene instructions were performed at baseline. PI measurements and OHSE&#xD;
      questionnaire were repeated at 1 and 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed</measure>
    <time_frame>baseline</time_frame>
    <description>Woelber et al. in 2015</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;change&quot; is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better), summed</measure>
    <time_frame>1 mouth</time_frame>
    <description>Woelber et al. in 2015</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;change&quot; is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed</measure>
    <time_frame>3 mouth</time_frame>
    <description>Woelber et al. in 2015</description>
  </primary_outcome>
  <primary_outcome>
    <measure>plaque index (min:0, max:5, lower values represent a better), averaged</measure>
    <time_frame>baseline</time_frame>
    <description>Quigley &amp; Hein (1962) Plaque Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;change&quot; is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged</measure>
    <time_frame>1 month</time_frame>
    <description>Quigley &amp; Hein (1962) Plaque Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;change&quot; is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged</measure>
    <time_frame>3 month</time_frame>
    <description>Quigley &amp; Hein (1962) Plaque Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General Self Efficacy (GSE) score (min:10, max: 40), summed</measure>
    <time_frame>baseline</time_frame>
    <description>Schwarzer &amp; Jerusalem, 1995</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic variables</measure>
    <time_frame>baseline</time_frame>
    <description>age, gender, smoking, number of teeth, education, income</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">52</enrollment>
  <condition>Dental Plaque</condition>
  <arm_group>
    <arm_group_label>2 groups: OHSE-high and OHSE-low</arm_group_label>
    <description>OHSE-high: Group with ≥ 50 OHSE scores received motivation and oral hygiene instructions .&#xD;
OHSE-low: Group with &lt; 30 OHSE scores received motivation and oral hygiene instructions .</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>motivation and and oral hygiene instructions</intervention_name>
    <description>Motivation and oral hygiene instructions were received OHSE-high and OHSE-low groups. After showing the modified-Bass tooth brushing technique and interdental cleaning on the model, patients were followed up while brushing and flossing their teeth to correct misapplications. It was advised to brush teeth twice a day and use the interdental cleaning devices once a day.</description>
    <arm_group_label>2 groups: OHSE-high and OHSE-low</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Gingivitis and periodontitis patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria were being able to brushing and interdental cleaning physically and&#xD;
        mentally, between the ages of 35 and 60, graduated from high school or university, having&#xD;
        at least 12 teeth, no periodontal treatment in the last 6 months, no periodontal surgery in&#xD;
        the last 2 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with one or more of the following criteria were excluded from the study: patients&#xD;
        having hepatitis or HIV infectious disease, pregnant and lactating females, patients taking&#xD;
        drugs that may cause gingival bleeding and gingival enlargement, and bleeding problems&#xD;
        (thrombocytopenia, hemophilia A-B, iron deficiency anemia etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gul Atilla</last_name>
    <role>Principal Investigator</role>
    <affiliation>clinical professor</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Gul Atilla</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Plaque</mesh_term>
  </condition_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/NCT03782311
org study id: c37taicm
nct id: NCT03782311
lead sponsor: 
The objectives are a) to determine the scores of general self-efficacy (GSE) and oral hygiene
      related self-efficacy (OHSE) b) to evaluate the relations between the scores of GSE and OHSE
      c) to examine the changes in OHSE scores and the relationship between OHSE and PI scores
      after motivation and oral hygiene instructions. OHSE scores could be an indicator in
      predicting daily plaque control of patients. Also, it may be needed to show greater interest
      about motivation and oral hygiene instructions especially for smokers and OHSE-low group
      patients.
All study patients (n=210) between the ages of 35 to 60 with inflammatory periodontal
      diseases filled out questionnaires regarding GSE and OHSE. Subgroups including OHSE-low
      (n=26) and OHSE-high (n=26) groups were selected after performing "cut off" on OHSE scores of
      all study patients. In both subgroups, plaque index (PI) values were determined, and
      motivation and oral hygiene instructions were performed at baseline. PI measurements and OHSE
      questionnaire were repeated at 1 and 3 months.
observational model: Cohort
time perspective: Prospective
measure: oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed
time frame: baseline
description: Woelber et al. in 2015
measure: "change" is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better), summed
time frame: 1 mouth
description: Woelber et al. in 2015
measure: "change" is being assessed. oral hygiene related self-efficacy (OHSE) score (min:19, max:76, higher values represent a better ), summed
time frame: 3 mouth
description: Woelber et al. in 2015
measure: plaque index (min:0, max:5, lower values represent a better), averaged
time frame: baseline
description: Quigley & Hein (1962) Plaque Index
measure: "change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged
time frame: 1 month
description: Quigley & Hein (1962) Plaque Index
measure: "change" is being assessed. plaque index (min:0, max:5, lower values represent a better), averaged
time frame: 3 month
description: Quigley & Hein (1962) Plaque Index
measure: General Self Efficacy (GSE) score (min:10, max: 40), summed
time frame: baseline
description: Schwarzer & Jerusalem, 1995
measure: Demographic variables
time frame: baseline
description: age, gender, smoking, number of teeth, education, income
arm group label: 2 groups: OHSE-high and OHSE-low
description: OHSE-high: Group with ≥ 50 OHSE scores received motivation and oral hygiene instructions .
OHSE-low: Group with < 30 OHSE scores received motivation and oral hygiene instructions .
intervention type: Behavioral
intervention name: motivation and and oral hygiene instructions
description: Motivation and oral hygiene instructions were received OHSE-high and OHSE-low groups. After showing the modified-Bass tooth brushing technique and interdental cleaning on the model, patients were followed up while brushing and flossing their teeth to correct misapplications. It was advised to brush teeth twice a day and use the interdental cleaning devices once a day.
arm group label: 2 groups: OHSE-high and OHSE-low
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gul Atilla
role: Principal Investigator
affiliation: clinical professor
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Gul Atilla
investigator title: Clinical Professor
mesh term: Dental Plaque