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Oral Health Promotion Among Preschool Children With Special Needs

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ClinicalTrials.gov Identifier: NCT03522337
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Gloria Hai-Ming Wong, The University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Intellectual Disability Cerebral Palsy Developmental Disorders Developmental Delay Autistic Spectrum Disorders Down Syndrome Epilepsy Developmental Disability Learning Disorders Other: Visual pedagogy (social stories) Other: Conventional leaflets Not Applicable

Detailed Description:

Early childhood caries (ECC) is reported to be the most prevalent childhood disease. It is a chronic, infectious dental disease affecting children aged between birth and 71 months. Untreated ECC can lead to toothache, swelling, abscess, immature loss of primary teeth, and thereby, significant impacts on children's physical and emotional status. Nowadays, ECC has been recognised as a serious public health problem in developing as well as developed countries. Although ECC has a complex aetiology, existing evidence reveals that tooth brushing, appropriate eating habits, and regular dental check-ups are effective in preventing the development of ECC.

In this study, oral health education will be reinforced by a series of visual education materials (social stories or conventional leaflets), which covering the three topics in ECC prevention, namely "tooth brushing", "healthy diets", and "dental visit". Sample size calculation is performed by the program G* power 3.1.9.2. The primary outcome is the development of new dental caries over the 24-month study period. Clinical oral examinations will be performed according to the following criteria: i) Caries experiences were assessed by the International Caries Detection and Assessment System(ICDAS); ii) Oral hygiene status by Simplified oral hygiene index of Greene and Vermilion (OHI-S); iii) gingival health status by Modified Gingival Index of Lobene (MGI). Dental examination will be performed at Special Child Care Centres by a paediatric dentist with a disposable mouth-mirror attached to an LED light. Tell- Show-Do (TSD) technique will be used to improve children's cooperation level. Tooth-brushing performance will be assessed by two observers. After dental examination and tooth-brushing assessment, a standard hands-on tooth-brushing training will be provided immediately to each child and his/her parent. Oral health instruction will also be illustrated to the participants, reinforced by social stories (experiment group) or conventional leaflets (control group). Questionnaires regarding children's oral health related behaviours and family demographic information will be completed by parents, while children's developmental profile will be assessed by staff in Special Child Care Centres. Children' oral health status and expected behaviours (tooth brushing, healthy eating habits and dental-visit experience) will be assessed at 6-month, 12-month and 24-month intervals.

All the data will be analysed using IBM SPSS. Continuous valuables such as dmft, dmfs, S-OHI, MGI scores between the control and test groups will be analysed by two-sample t test, paired-t test, Mann-Whitney Test when appropriate. Chi-square statistics will be used to assess the differences in categorical variables between control group and test group, such as caries incidence, tooth-brushing frequencies, snacking frequencies, and dental-visit frequencies. McNemar's test will be used to analyse whether children's oral-health related behaviours will be changed before and after intervention. Regression analyses will be conducted to determine potential factors associated with children's oral health status or oral-health related behaviours in the model. The significance levels will be set to be P < 0.05.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effectiveness of Visual Pedagogy-assisted Tooth-brushing Training Among Preschoolers With Special Needs for Oral Health Promotion
Actual Study Start Date : April 12, 2016
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control group
The main intervention is conventional leaflets. Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by leaflets.
Other: Conventional leaflets
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Other Name: Behavioral

Experimental: Test group
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)
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Other Name: Behavioral




Primary Outcome Measures :
  1. Change in carious tooth surfaces over course of the trial [ Time Frame: The change from baseline to 24 months ]
    Assessed by the International Caries Detection and Assessment System(ICDAS)

  2. Change in the prevalence of dental caries [ Time Frame: The change from baseline to 24 months ]
    Measured by dmft index (decayed, missing due to caries, and filled primary teeth)


Secondary Outcome Measures :
  1. Change in oral hygiene status [ Time Frame: 6 months, 12 months, 24 months ]
    Assessed by simplified oral hygiene index (S-OHI)

  2. Change in gingival status [ Time Frame: 6 months, 12 months, 24 months ]
    Assessed by modified gingival index (MGI)

  3. Change in children's tooth-brushing performance [ Time Frame: 6 months, 12 months, 24 months ]
    Observed and assessed by investigators using the step-based assessment tool, and tooth-brushing duration will be recorded by a timer

  4. Change in children's eating habits [ Time Frame: 12 months, 24 months ]
    Questionnaires regarding children's oral health-related eating habits will be completed by parents

  5. Change in children's dental-visit experience [ Time Frame: 24 months ]
    Questionnaires regarding children's dental-visit experience will be completed by parents

  6. The amount of toothpaste [ Time Frame: Immediately after dentists demonstrating the appropriate amount of toothpaste for children younger than 6 years old ]
    The weight of toothpaste dispensed by parents and/or children during tooth-brushing training

  7. Toothbrush wear [ Time Frame: 6 months, 12 months, 24 months ]
    Assessed by toothbrush wear index (Rawls,1989)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522337


Contacts
Contact: Hai Ming Wong Clinical associate professor, PhD +852-28590261 wonghmg@hku.hk

Locations
China, Hong Kong
Dental Faculty, The University of Hong Kong Recruiting
Hong Kong, Hong Kong, China
Contact: Hai Ming Wong, PhD    +852-28590261    wonghmg@hku.hk   
Principal Investigator: Hai Ming Wong, PhD         
Sub-Investigator: Ni ZHOU         
Sub-Investigator: Colman McGrath, PhD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Hai Ming Wong, PhD Dental Faculty, The University of Hong Kong
  Study Documents (Full-Text)

Documents provided by Dr. Gloria Hai-Ming Wong, The University of Hong Kong:
Statistical Analysis Plan  [PDF] November 22, 2015
Study Protocol  [PDF] November 22, 2015


Responsible Party: Dr. Gloria Hai-Ming Wong, Associate professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03522337     History of Changes
Other Study ID Numbers: SCCC2016to2018
HKUCTR-2015 ( Registry Identifier: HKU Clinical Trials Registry (HKUCTR) )
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the relevant studies have been published, Statistical Analysis Plan and Clinical Study Report will be shared.
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Relevant date will be shared 6 months later after the summary data are published.
Access Criteria: E-mail

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Gloria Hai-Ming Wong, The University of Hong Kong:
preschool children
special needs
tooth brushing
social story
visual pedagogy

Additional relevant MeSH terms:
Disease
Cerebral Palsy
Down Syndrome
Intellectual Disability
Developmental Disabilities
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Learning Disorders
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Communication Disorders