<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/NCT03791385</url>
  </required_header>
  <id_info>
    <org_study_id>20110011</org_study_id>
    <nct_id>NCT03791385</nct_id>
  </id_info>
  <brief_title>Effectiveness of Picture Exchange Communication System on Gingival Health of Children With Autism Spectrum Disorders</brief_title>
  <official_title>Effectiveness of Picture Exchange Communication System (PECS) on Dental Plaque and Gingival Health of Children With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jordan University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Picture Exchange Communication System (PECS) is a communication system for children with&#xD;
      autism spectrum disorders (ASD). The aim of this study was to assess the effect of a&#xD;
      PECS-based tooth-brushing program on gingival health in children with ASD and assess parents'&#xD;
      perception of PECS. This was a prospective interventional study. Using PECS as a&#xD;
      pictures/cards series showing a structured tooth-brushing method, 37 children with ASD (31&#xD;
      males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were&#xD;
      trained on tooth-brushing twice, two weeks apart. Data collected after examinations&#xD;
      (baseline, 3, 6-months) included gingival and plaque indices (GI, PI) and two questionnaires&#xD;
      (baseline, 6-months) for demographic data and parents' perception of PECS including:&#xD;
      difficulty rating (easy, hard, very hard) and PECS usefulness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The need for improved oral hygiene routines in individuals with autism spectrum disorders&#xD;
      (ASD) has been documented in many reports. The Picture Exchange Communication System (PECS),&#xD;
      which is a series of pictures that show a structured method and technique for teeth brushing,&#xD;
      was chosen for this study since it is a proven communication system for children with autism&#xD;
      spectrum disorders (ASD).&#xD;
&#xD;
      The aim of the study was to assess the effect of a PECS-based tooth-brushing program on&#xD;
      gingival health in children with ASD and assess parents' perception of PECS.&#xD;
&#xD;
      This was a prospective interventional study. Using PECS as a pictures/cards series showing a&#xD;
      structured tooth-brushing method, 37 children with ASD (31 males, 6 females) (average age&#xD;
      9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two&#xD;
      weeks apart. The pictures were placed in the bathroom, at home and/or at the autism center.&#xD;
      Data collected after examinations (baseline, 3, 6-months) included gingival and plaque&#xD;
      indices (GI, PI) and two questionnaires (baseline, 6-months) for demographic data and&#xD;
      parents' perception of PECS including: difficulty rating (easy, hard, very hard) and whether&#xD;
      they found PECS useful in teaching their children how to brush their teeth (yes or no).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2011</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Children with ASD ages 4-16 years</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gingival index score</measure>
    <time_frame>6 months</time_frame>
    <description>This score indicates the level of gingival inflammation upon examination of teeth, reported as the average score calculated as (total score for all teeth/number of examined teeth): Score 0 (Absence of inflammation), Score 1 (Mild inflammation: slight change in colour (more red) and little change in texture (loss of stippling), No bleeding on probing), Score 2 (Moderate inflammation: moderate glazing, redness, edema and hypertrophy; bleeding on probing), Score 3 (Severe inflammation: marked redness and edema; tendency to spontaneous bleeding; ulceration). A lower score indicates less gingival inflammation (better gingival health) and vice versa.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plaque index score</measure>
    <time_frame>6 months</time_frame>
    <description>This score indicates the level of plaque (and reflects level of oral hygiene) upon examination of teeth, reported as the average score, calculated as (total score for all teeth/number of examined teeth): Score 0 (No plaque), Score 1 (Plaque not visible by eye, only detectable using a dental probe), Score 2 (Plaque visible by eye &amp; detectable with a dental probe along the gingival margin of the tooth), Score 4 (Thick layer of plaque visible by eye &amp; detectable by probe covering more than the gingival margin of the tooth). A lower score indicates less plaque (meaning better oral hygiene) and vice versa.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parents' rating of PECS difficulty</measure>
    <time_frame>6 months</time_frame>
    <description>Parents were asked to rate PECS difficulty as: easy, hard, very hard. This was assessed through a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PECS usefulness</measure>
    <time_frame>6 months</time_frame>
    <description>Parents were asked whether PECS was useful in teaching their children how to brush their teeth: yes, no. This was assessed through a questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Study subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children with ASD and their parents/caregivers were trained on tooth-brushing twice, two weeks apart using Picture Exchange Communication System (PECS) PECS as a pictures/cards series showing a structured tooth-brushing method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Picture Exchange Communication System (PECS)</intervention_name>
    <description>A communication system frequently used with non-verbal children with autism spectrum disorders (ASD) that uses a series of pictures that describe how a certain activity is done, in our case showing a structured method and technique for teeth brushing.</description>
    <arm_group_label>Study subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children diagnosed with ASD.&#xD;
&#xD;
          -  Age between 4 and 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children unable to cooperate for data collection (poor behavior during dental&#xD;
             examination).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ola B Al-Batayneh</last_name>
    <role>Study Director</role>
    <affiliation>Jordan University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jordan University of Science and Technology</name>
      <address>
        <city>Irbid</city>
        <zip>22110</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <reference>
    <citation>Pilebro C, Backman B. Teaching oral hygiene to children with autism. Int J Paediatr Dent. 2005 Jan;15(1):1-9. doi: 10.1111/j.1365-263X.2005.00589.x.</citation>
    <PMID>15663439</PMID>
  </reference>
  <reference>
    <citation>Charlop-Christy MH, Carpenter M, Le L, LeBlanc LA, Kellet K. Using the picture exchange communication system (PECS) with children with autism: assessment of PECS acquisition, speech, social-communicative behavior, and problem behavior. J Appl Behav Anal. 2002 Fall;35(3):213-31. doi: 10.1901/jaba.2002.35-213.</citation>
    <PMID>12365736</PMID>
  </reference>
  <reference>
    <citation>Lerna A, Esposito D, Conson M, Massagli A. Long-term effects of PECS on social-communicative skills of children with autism spectrum disorders: a follow-up study. Int J Lang Commun Disord. 2014 Jul-Aug;49(4):478-85. doi: 10.1111/1460-6984.12079. Epub 2014 Mar 21.</citation>
    <PMID>24655345</PMID>
  </reference>
  <reference>
    <citation>Eslami N, Movahed T, Asadi M. Parents' Perceptions of the Oral Health-related Quality of Life of their Autistic Children in Iran. J Clin Pediatr Dent. 2018;42(6):422-426. doi: 10.17796/1053-4625-42.6.3. Epub 2018 Aug 7.</citation>
    <PMID>30085870</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 29, 2018</last_update_submitted>
  <last_update_submitted_qc>December 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism Spectrum Disorder</keyword>
  <keyword>Picture Exchange Communication System (PECS)</keyword>
  <keyword>Tooth-brushing program</keyword>
  <keyword>Gingival index</keyword>
  <keyword>Plaque index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT03791385
org study id: 20110011
nct id: NCT03791385
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Picture Exchange Communication System (PECS) is a communication system for children with
      autism spectrum disorders (ASD). The aim of this study was to assess the effect of a
      PECS-based tooth-brushing program on gingival health in children with ASD and assess parents'
      perception of PECS. This was a prospective interventional study. Using PECS as a
      pictures/cards series showing a structured tooth-brushing method, 37 children with ASD (31
      males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were
      trained on tooth-brushing twice, two weeks apart. Data collected after examinations
      (baseline, 3, 6-months) included gingival and plaque indices (GI, PI) and two questionnaires
      (baseline, 6-months) for demographic data and parents' perception of PECS including:
      difficulty rating (easy, hard, very hard) and PECS usefulness.
The need for improved oral hygiene routines in individuals with autism spectrum disorders
      (ASD) has been documented in many reports. The Picture Exchange Communication System (PECS),
      which is a series of pictures that show a structured method and technique for teeth brushing,
      was chosen for this study since it is a proven communication system for children with autism
      spectrum disorders (ASD).

      The aim of the study was to assess the effect of a PECS-based tooth-brushing program on
      gingival health in children with ASD and assess parents' perception of PECS.

      This was a prospective interventional study. Using PECS as a pictures/cards series showing a
      structured tooth-brushing method, 37 children with ASD (31 males, 6 females) (average age
      9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two
      weeks apart. The pictures were placed in the bathroom, at home and/or at the autism center.
      Data collected after examinations (baseline, 3, 6-months) included gingival and plaque
      indices (GI, PI) and two questionnaires (baseline, 6-months) for demographic data and
      parents' perception of PECS including: difficulty rating (easy, hard, very hard) and whether
      they found PECS useful in teaching their children how to brush their teeth (yes or no).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Children with ASD ages 4-16 years
primary purpose: Supportive Care
masking: None (Open Label)
measure: Gingival index score
time frame: 6 months
description: This score indicates the level of gingival inflammation upon examination of teeth, reported as the average score calculated as (total score for all teeth/number of examined teeth): Score 0 (Absence of inflammation), Score 1 (Mild inflammation: slight change in colour (more red) and little change in texture (loss of stippling), No bleeding on probing), Score 2 (Moderate inflammation: moderate glazing, redness, edema and hypertrophy; bleeding on probing), Score 3 (Severe inflammation: marked redness and edema; tendency to spontaneous bleeding; ulceration). A lower score indicates less gingival inflammation (better gingival health) and vice versa.
measure: Plaque index score
time frame: 6 months
description: This score indicates the level of plaque (and reflects level of oral hygiene) upon examination of teeth, reported as the average score, calculated as (total score for all teeth/number of examined teeth): Score 0 (No plaque), Score 1 (Plaque not visible by eye, only detectable using a dental probe), Score 2 (Plaque visible by eye & detectable with a dental probe along the gingival margin of the tooth), Score 4 (Thick layer of plaque visible by eye & detectable by probe covering more than the gingival margin of the tooth). A lower score indicates less plaque (meaning better oral hygiene) and vice versa.
measure: Parents' rating of PECS difficulty
time frame: 6 months
description: Parents were asked to rate PECS difficulty as: easy, hard, very hard. This was assessed through a questionnaire.
measure: PECS usefulness
time frame: 6 months
description: Parents were asked whether PECS was useful in teaching their children how to brush their teeth: yes, no. This was assessed through a questionnaire.
arm group label: Study subjects
arm group type: Experimental
description: Children with ASD and their parents/caregivers were trained on tooth-brushing twice, two weeks apart using Picture Exchange Communication System (PECS) PECS as a pictures/cards series showing a structured tooth-brushing method.
intervention type: Behavioral
intervention name: Picture Exchange Communication System (PECS)
description: A communication system frequently used with non-verbal children with autism spectrum disorders (ASD) that uses a series of pictures that describe how a certain activity is done, in our case showing a structured method and technique for teeth brushing.
arm group label: Study subjects
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ola B Al-Batayneh
role: Study Director
affiliation: Jordan University of Science and Technology
facility: 
country: Jordan
citation: Pilebro C, Backman B. Teaching oral hygiene to children with autism. Int J Paediatr Dent. 2005 Jan;15(1):1-9. doi: 10.1111/j.1365-263X.2005.00589.x.
PMID: 15663439
citation: Charlop-Christy MH, Carpenter M, Le L, LeBlanc LA, Kellet K. Using the picture exchange communication system (PECS) with children with autism: assessment of PECS acquisition, speech, social-communicative behavior, and problem behavior. J Appl Behav Anal. 2002 Fall;35(3):213-31. doi: 10.1901/jaba.2002.35-213.
PMID: 12365736
citation: Lerna A, Esposito D, Conson M, Massagli A. Long-term effects of PECS on social-communicative skills of children with autism spectrum disorders: a follow-up study. Int J Lang Commun Disord. 2014 Jul-Aug;49(4):478-85. doi: 10.1111/1460-6984.12079. Epub 2014 Mar 21.
PMID: 24655345
citation: Eslami N, Movahed T, Asadi M. Parents' Perceptions of the Oral Health-related Quality of Life of their Autistic Children in Iran. J Clin Pediatr Dent. 2018;42(6):422-426. doi: 10.17796/1053-4625-42.6.3. Epub 2018 Aug 7.
PMID: 30085870
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive