NCT06588062

Brief Summary

Background: Oral health is an important part of overall health of the children and precisely it is additionally imperative for children who need out of the ordinary or special health care. Children with autism spectrum disorder normally face trouble in maintenance of good oral hygiene due to their incapacity to communicate and interact socially and are one such group lacking sufficient oral health knowledge to sustain their oral health owing to communication barriers. Objective: To assess and compare the effect of Picture Exchange Communication System (PECS) intervention on oral hygiene status of preschool children (aged 4 to 6 years old) with Autism Spectrum Disorder (ASD) over a period of three months. Methods: Children with confirmed diagnosis of autism will be randomly divided into two groups. All the participants of both the groups, intervention (Group I) and control (Group II) will receive conventional oral hygiene instructions in presence of their parents. These instructions will be given on model, showing each surface to be cleaned properly. Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes. Moreover, instruction to avoid sugary diet will also be given. Additionally, the intervention participants (Group I) will be provided a set of 10 picture cards depicting brushing sequences and techniques by animated character for PECS intervention. The plaque scores will be recorded in the two groups by using PI index by Silness \& Loe (1964), GI scores will also be recorded by using GI index Loe \& Silness (1963) using a periodontal probe at baseline. Following the initial examination, oral health education will be given on model to both groups, in addition to this (Group I) will be demonstrated to use PECS intervention. After three months follow up visit will be conducted in which plaque and gingival scores will be recorded again in both groups to assess the impact of PECS intervention on oral hygiene status of children with ASD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

September 5, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

oral health statuschildpreschoolautism spectrum disorder

Outcome Measures

Primary Outcomes (2)

  • Plaque Index (PI)

    The outcome measure will be evaluated in follow up examination after a period of three months by defining changes observed in PI scores calculated before and after intervention applied.

    Three Month

  • Gingival Index (GI)

    The outcome measures will be evaluated in follow up examination after a period of three months by defining changes observed in GI scores calculated before and after intervention applied.

    Three month

Study Arms (2)

Intervention Group I

EXPERIMENTAL

All the participants of intervention (Group I) will receive conventional oral hygiene instructions in presence of their parents. These instructions will be given on model, showing each surface to be cleaned properly. Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes. Moreover, avoidance of sugary diet will also be given. In addition the intervention participants (Group I) will be provided with PECS tool to be utilized during tooth brushing. It will be a set of 10 picture cards depicting brushing sequence and techniques by animated character. The picture will be illustrating brushing of left and right buccal, lingual, labial, and occlusal surfaces of maxillary and mandibular teeth. Each card will be accompanied by the instructions of specific step of technique with clear picture illustration for better understanding. The same instructions will be provided again, one week apart for development of skills.

Other: Picture Exchange Communication System (PECS)

Control Group II

NO INTERVENTION

All the participants of control (Group II) will receive conventional oral hygiene instructions in presence of their parents. These instructions will be given on model, showing each surface to be cleaned properly. Tooth brushing with the Horizontal Scrub Technique will be promoted and performance of brushing twice daily for 2 minutes. Moreover, avoidance of sugary diet will also be given. However, PECS tool is not used as an intervention in this group. The same instructions will be provided again, one week apart for development of skills.

Interventions

Picture exchange communication System (PECS) is a widely useful tool for developing skills in ASD children. Visual supports rather work better for their intellectual level as these children usually respond less to verbal and written instructions. PECS is considered as an augmentative communication system commonly used with non-verbal ASD children. It is helpful for an individual with ASD to quickly acquire a functional means of communication. This is highly beneficial for the child to communicate with his parents and caregivers, as well as with their peers. Moreover, the pictorial approach of PECS is a source of facilitating element in attaining student's concentration. The reason for wide acceptance of this tool in clinical and social settings for children with ASD is its' ease of use, ability to teach two-way communication and inexpensiveness. PECS has demonstrated successful use in teaching various skills in ASD affected children lacking speech.

Intervention Group I

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with Confirmed diagnosis of ASD classified on the basis of CARS score 30-36.5 who understand visual or simple verbal instructions.
  • Age range between 4 to 6 years
  • Cooperative for oral examination

You may not qualify if:

  • ASD children with any systemic disease which can affect oral health.
  • Identification of any oral condition requiring immediate dental treatment.
  • Multiple disabilities, down syndrome, epilepsy patients.
  • Taking drugs such as anticonvulsant, antidepressants, anti-anxiety which can affect oral cavity tissues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75330, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDS Trainee

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

May 1, 2023

Primary Completion

July 31, 2023

Study Completion

September 29, 2023

Last Updated

September 19, 2024

Record last verified: 2024-05

Locations