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Effectiveness of Picture Exchange Communication System on Gingival Health of Children With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Picture Exchange Communication System (PECS)
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Picture Exchange Communication System (PECS), Tooth-brushing program, Gingival index, Plaque index

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children diagnosed with ASD.
  • Age between 4 and 18 years old.

Exclusion Criteria:

  • Children unable to cooperate for data collection (poor behavior during dental examination).

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study subjects

Arm 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.

Outcomes

Primary Outcome Measures

Gingival index score
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.
Plaque index score
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.

Secondary Outcome Measures

Parents' rating of PECS difficulty
Parents were asked to rate PECS difficulty as: easy, hard, very hard. This was assessed through a questionnaire.
PECS usefulness
Parents were asked whether PECS was useful in teaching their children how to brush their teeth: yes, no. This was assessed through a questionnaire.

Full Information

First Posted
December 23, 2018
Last Updated
December 29, 2018
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03791385
Brief Title
Effectiveness of Picture Exchange Communication System on Gingival Health of Children With Autism Spectrum Disorders
Official Title
Effectiveness of Picture Exchange Communication System (PECS) on Dental Plaque and Gingival Health of Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Picture Exchange Communication System (PECS), Tooth-brushing program, Gingival index, Plaque index

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children with ASD ages 4-16 years
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study subjects
Arm Type
Experimental
Arm 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(s)
Picture Exchange Communication System (PECS)
Intervention 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.
Primary Outcome Measure Information:
Title
Gingival index score
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.
Time Frame
6 months
Title
Plaque index score
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parents' rating of PECS difficulty
Description
Parents were asked to rate PECS difficulty as: easy, hard, very hard. This was assessed through a questionnaire.
Time Frame
6 months
Title
PECS usefulness
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children diagnosed with ASD. Age between 4 and 18 years old. Exclusion Criteria: Children unable to cooperate for data collection (poor behavior during dental examination).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola B Al-Batayneh
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15663439
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.
Results Reference
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PubMed Identifier
12365736
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.
Results Reference
background
PubMed Identifier
24655345
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.
Results Reference
background
PubMed Identifier
30085870
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.
Results Reference
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Effectiveness of Picture Exchange Communication System on Gingival Health of Children With Autism Spectrum Disorders

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