Oral Health Promotion Among Preschool Children With Special Needs
Primary Purpose
Intellectual Disability, Cerebral Palsy, Developmental Disorders
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Visual pedagogy (social stories)
Conventional leaflets
Sponsored by
About this trial
This is an interventional prevention trial for Intellectual Disability focused on measuring preschool children, special needs, tooth brushing, social story, visual pedagogy
Eligibility 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.
Sites / Locations
- Dental Faculty, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Test group
Arm Description
The main intervention is conventional leaflets. Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by leaflets.
The main intervention is visual pedagogy (social stories). Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by social stories.
Outcomes
Primary Outcome Measures
Change in carious tooth surfaces over course of the trial
Assessed by the International Caries Detection and Assessment System(ICDAS)
Change in the prevalence of dental caries
Measured by dmft index (decayed, missing due to caries, and filled primary teeth)
Secondary Outcome Measures
Change in oral hygiene status
Assessed by simplified oral hygiene index (S-OHI)
Change in gingival status
Assessed by modified gingival index (MGI)
Change in children's tooth-brushing performance
Observed and assessed by investigators using the step-based assessment tool, and tooth-brushing duration will be recorded by a timer
Change in children's eating habits
Questionnaires regarding children's oral health-related eating habits will be completed by parents
Change in children's dental-visit experience
Questionnaires regarding children's dental-visit experience will be completed by parents
The amount of toothpaste
The weight of toothpaste dispensed by parents and/or children during tooth-brushing training
Toothbrush wear
Assessed by toothbrush wear index (Rawls,1989)
Full Information
NCT ID
NCT03522337
First Posted
April 18, 2018
Last Updated
April 17, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03522337
Brief Title
Oral Health Promotion Among Preschool Children With Special Needs
Official Title
Effectiveness of Visual Pedagogy-assisted Tooth-brushing Training Among Preschoolers With Special Needs for Oral Health Promotion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2016 (Actual)
Primary Completion Date
September 28, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The main intervention is conventional leaflets. Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by leaflets.
Arm Title
Test group
Arm Type
Experimental
Arm Description
The main intervention is visual pedagogy (social stories). Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by social stories.
Intervention Type
Other
Intervention Name(s)
Visual pedagogy (social stories)
Other Intervention Name(s)
Behavioral
Intervention Description
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Intervention Type
Other
Intervention Name(s)
Conventional leaflets
Other Intervention Name(s)
Behavioral
Intervention Description
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Primary Outcome Measure Information:
Title
Change in carious tooth surfaces over course of the trial
Description
Assessed by the International Caries Detection and Assessment System(ICDAS)
Time Frame
The change from baseline to 24 months
Title
Change in the prevalence of dental caries
Description
Measured by dmft index (decayed, missing due to caries, and filled primary teeth)
Time Frame
The change from baseline to 24 months
Secondary Outcome Measure Information:
Title
Change in oral hygiene status
Description
Assessed by simplified oral hygiene index (S-OHI)
Time Frame
6 months, 12 months, 24 months
Title
Change in gingival status
Description
Assessed by modified gingival index (MGI)
Time Frame
6 months, 12 months, 24 months
Title
Change in children's tooth-brushing performance
Description
Observed and assessed by investigators using the step-based assessment tool, and tooth-brushing duration will be recorded by a timer
Time Frame
6 months, 12 months, 24 months
Title
Change in children's eating habits
Description
Questionnaires regarding children's oral health-related eating habits will be completed by parents
Time Frame
12 months, 24 months
Title
Change in children's dental-visit experience
Description
Questionnaires regarding children's dental-visit experience will be completed by parents
Time Frame
24 months
Title
The amount of toothpaste
Description
The weight of toothpaste dispensed by parents and/or children during tooth-brushing training
Time Frame
Immediately after dentists demonstrating the appropriate amount of toothpaste for children younger than 6 years old
Title
Toothbrush wear
Description
Assessed by toothbrush wear index (Rawls,1989)
Time Frame
6 months, 12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hai Ming Wong, PhD
Organizational Affiliation
Dental Faculty, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Faculty, The University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the relevant studies have been published, Statistical Analysis Plan and Clinical Study Report will be shared.
IPD Sharing Time Frame
Relevant date will be shared 6 months later after the summary data are published.
IPD Sharing Access Criteria
E-mail
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Oral Health Promotion Among Preschool Children With Special Needs
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