Oral Health Promotion Among Preschool Children With Special Needs

NCT03522337 | Completed

• 2 other identifiers: SCCC2016to2018HKUCTR-2015
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Establishing good oral health-related habit is challenging among younger children, especially for preschool children with special needs, as they have physical, mental, sensory, behavioural, emotional, and chronic medical conditions that requires health care beyond the routines. Existing evidences showed that children with special needs have poorer oral health status and more challenging behaviours than their counterparts in main stream schools. Visual pedagogy, such as social stories, have been applied to teach a variety of skills or behaviours to individuals with special needs. They are short stories demonstrating the target skill or behaviour, and then the readers are expected to perform the target skill or behaviour following the demonstrations. Giving the evidence that children with special needs can understand complex situations and learn new practices by using those stories, we expect to apply a package of structured social stories to modify oral health-related behaviours (tooth brushing, healthy eating, dental visit), and thereby, improve oral health status among preschool children with special needs. Establishment of good oral-health related behaviours in early childhood will benefits children in their future life. Additionally, visual pedagogy-assisted oral health education is relatively easy and safe to implement. If proven effective, social story-based preventive care can be recommended to special children globally.

Conditions

Intellectual Disability; Cerebral Palsy; Developmental Disorders; Developmental Delay; Autistic Spectrum Disorders; Down Syndrome; Epilepsy; Developmental Disability; Learning Disorders

Keywords

preschool children; special needs; tooth brushing; social story; visual pedagogy

Outcome Measures

Primary Outcomes (2)

• Change in carious tooth surfaces over course of the trial

  Assessed by the International Caries Detection and Assessment System(ICDAS)

  The change from baseline to 24 months

• Change in the prevalence of dental caries

  Measured by dmft index (decayed, missing due to caries, and filled primary teeth)

  The change from baseline to 24 months

Secondary Outcomes (7)

• Change in oral hygiene status

  6 months, 12 months, 24 months

• Change in gingival status

  6 months, 12 months, 24 months

• Change in children's tooth-brushing performance

  6 months, 12 months, 24 months

• Change in children's eating habits

  12 months, 24 months

• Change in children's dental-visit experience

  24 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

The main intervention is conventional leaflets. Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by leaflets.

Other: Conventional leaflets

Test group

EXPERIMENTAL

The main intervention is visual pedagogy (social stories). Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by social stories.

Other: Visual pedagogy (social stories)

Interventions

Visual pedagogy (social stories) OTHER

Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)

Also known as: Behavioral

Test group

Conventional leaflets OTHER

Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)

Also known as: Behavioral

Control group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preschool-aged children in Special Child Care Centres or special schools in Hong Kong

You may not qualify if:

• With severe visually impaired, severe hearing impaired (cannot hear dentists' or parents' instruction); severe physical disabled (cannot hold a toothbrush); requiring emergent dental treatment; use of antibiotic within 3 months; dental prophylaxes in the last 6 months.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Dental Faculty, The University of Hong Kong

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Intellectual Disability; Cerebral Palsy; Developmental Disabilities; Learning Disabilities; Autism Spectrum Disorder; Down Syndrome; Epilepsy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Communication Disorders; Child Development Disorders, Pervasive; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Hai Ming Wong, PhD

  Dental Faculty, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The randomised sequence will be generated by an investigator who does not participate in the outreach service. The allocation sequence will be sealed in an envelope, and opened at the Special Child Care Centres by an assistant. The assistant will be responsible for delivering the materials to children and their parents.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study is designed as a 24-month randomised, controlled, blind, parallel clinical trial conducted in Special Child Care Centres, aiming to promote oral health among preschool children with special needs.

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 11, 2018
• Study Start: April 12, 2016
• Primary Completion: September 28, 2018
• Study Completion: September 30, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Relevant date will be shared 6 months later after the summary data are published.
• Access Criteria: E-mail

Locations

CN (1)