<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/NCT03030014</url>
  </required_header>
  <id_info>
    <org_study_id>SShaalan</org_study_id>
    <nct_id>NCT03030014</nct_id>
  </id_info>
  <brief_title>Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children</brief_title>
  <official_title>Effect of Dental Educational Program on Oral Hygiene Status Among Institutionalized Deaf Children. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      assess the effect of dental educational program on oral hygiene among institutionalized&#xD;
      hearing impaired and mute children in Cairo, Egypt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Evaluate participants satisfaction regarding the dental educational program(learning&#xD;
           teeth brushing technique)&#xD;
&#xD;
        -  Measure the oral hygiene index simplified to the participants at a different follow up&#xD;
           periods for assessing the effect of the dental educational program on oral hygiene.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>6 weeks</time_frame>
    <description>this outcome will be assessed via questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oral hygiene index simplified</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">238</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>educational programm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.&#xD;
Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no educational programm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>without educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>educational programm</intervention_name>
    <description>Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.</description>
    <arm_group_label>educational programm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no educational program</intervention_name>
    <description>without oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.</description>
    <arm_group_label>no educational programm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged from 6-12 years with mixed dentition.&#xD;
&#xD;
          -  Institutionalized Deaf children in Cairo, Egypt.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children above the age of 12 years and below the age of 6 years&#xD;
&#xD;
          -  Patient un able to give informed consent&#xD;
&#xD;
          -  Patient suffering from any other type of disability such as (mental retardation,&#xD;
             physically and mentally handicapped, .etc.)&#xD;
&#xD;
          -  Medically compromised patient&#xD;
&#xD;
          -  Patient who were absent in the day of examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>February 6, 2017</last_update_submitted>
  <last_update_submitted_qc>February 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sohil Souod Ali Shaalan</investigator_full_name>
    <investigator_title>researcher at pedodontic department faculty of oral and dental medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</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/NCT03030014
org study id: SShaalan
nct id: NCT03030014
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
assess the effect of dental educational program on oral hygiene among institutionalized
      hearing impaired and mute children in Cairo, Egypt.
-  Evaluate participants satisfaction regarding the dental educational program(learning
           teeth brushing technique)

        -  Measure the oral hygiene index simplified to the participants at a different follow up
           periods for assessing the effect of the dental educational program on oral hygiene.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: patient satisfaction
time frame: 6 weeks
description: this outcome will be assessed via questionnaire
measure: oral hygiene index simplified
time frame: 6 weeks
arm group label: educational programm
arm group type: Experimental
description: Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.
Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
arm group label: no educational programm
arm group type: Placebo Comparator
description: without educational program Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
intervention type: Behavioral
intervention name: educational programm
description: Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
arm group label: educational programm
intervention type: Other
intervention name: no educational program
description: without oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
arm group label: no educational programm
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sohil Souod Ali Shaalan
investigator title: researcher at pedodontic department faculty of oral and dental medicine
mesh term: Hearing Loss