Intellectual DisabilityNCT03522337
Oral Health Promotion Among Preschool Children With Special Needs
A study testing Visual pedagogy (social stories) and Conventional leaflets in people with Intellectual Disability and Cerebral Palsy, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Intellectual Disability, Cerebral Palsy, Developmental Disorders
- What is being tested?
- Visual pedagogy (social stories) and Conventional leaflets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preschool-aged children in Special Child Care Centres or special schools in Hong Kong
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Visual Pedagogy-assisted Tooth-brushing Training Among Preschoolers With Special Needs for Oral Health Promotion
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.
Read the 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.
- Conditions
- Intellectual Disability, Cerebral Palsy, Developmental Disorders, Developmental Delay, Autistic Spectrum Disorders, Down Syndrome
- Being tested
- Visual pedagogy (social stories), Conventional leaflets
- Keywords
- preschool children, special needs, tooth brushing, social story, visual pedagogy
- Medical subject headings
- Intellectual Disability, Cerebral Palsy, Developmental Disabilities, Learning Disabilities, Autism Spectrum Disorder, Down Syndrome, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual pedagogy (social stories)Other
Also called Behavioral
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Conventional leafletsOther
Also called Behavioral
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Visual pedagogy (social stories) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carious tooth surfaces over course of the trial
Assessed by the International Caries Detection and Assessment System(ICDAS)
Measured: 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)
Measured: The change from baseline to 24 months
Secondary outcomes (7)
Change in oral hygiene status
Assessed by simplified oral hygiene index (S-OHI)
Measured: 6 months, 12 months, 24 months
Change in gingival status
Assessed by modified gingival index (MGI)
Measured: 6 months, 12 months, 24 months
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
Measured: 6 months, 12 months, 24 months
Change in children's eating habits
Questionnaires regarding children's oral health-related eating habits will be completed by parents
Measured: 12 months, 24 months
Change in children's dental-visit experience
Questionnaires regarding children's dental-visit experience will be completed by parents
Measured: 24 months
The amount of toothpaste
The weight of toothpaste dispensed by parents and/or children during tooth-brushing training
Measured: Immediately after dentists demonstrating the appropriate amount of toothpaste for children younger than 6 years old
Toothbrush wear
Assessed by toothbrush wear index (Rawls,1989)
Measured: 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start12 Apr 2016
- Primary completion28 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gloria Hai-Ming Wong, The University of Hong Kong
- Investigators
- Hai Ming Wong, PhD, Principal investigator, Dental Faculty, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522337
- Sponsor's protocol ID
- SCCC2016to2018
- Other IDs
- HKUCTR-2015
- Status last verified
- Apr 2019
- First submitted
- 18 Apr 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the relevant studies have been published, Statistical Analysis Plan and Clinical Study Report will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Visual Pedagogy-assisted Tooth-brushing Training Among Preschoolers With Special Needs for Oral Health Promotion
- ClinicalTrials.gov ID
- NCT03522337
- Acronym / sponsor ID
- SCCC2016to2018
- Conditions
- Intellectual Disability, Cerebral Palsy, Developmental Disorders, Developmental Delay, Autistic Spectrum Disorders, Down Syndrome
- Keywords
- preschool children, special needs, tooth brushing, social story, visual pedagogy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Conventional leafletsThe main intervention is conventional leaflets. Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by leaflets. |
| Test group | Experimental | Other: Visual pedagogy (social stories)The main intervention is visual pedagogy (social stories). Tooth-brushing training (toothbrushes and toothpastes provided) and oral health instruction are reinforced by social stories. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preschool-aged children in Special Child Care Centres or special schools in Hong Kong
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual pedagogy (social stories)Also: BehavioralOral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided) | Other | Test group |
| Conventional leafletsAlso: BehavioralOral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided) | Other | Control group |
Primary outcome
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)
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)
7 secondary outcomes
Change in oral hygiene status
Time frame: 6 months, 12 months, 24 months
Change in gingival status
Time frame: 6 months, 12 months, 24 months
Change in children's tooth-brushing performance
Time frame: 6 months, 12 months, 24 months
Change in children's eating habits
Time frame: 12 months, 24 months
Change in children's dental-visit experience
Time frame: 24 months
The amount of toothpaste
Time frame: Immediately after dentists demonstrating the appropriate amount of toothpaste for children younger than 6 years old
Toothbrush wear
Time frame: 6 months, 12 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: Yes. After the relevant studies have been published, Statistical Analysis Plan and Clinical Study Report will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hai Ming Wong, PhD principal investigator
Dental Faculty, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual pedagogy (social stories) and Conventional leaflets in people with Intellectual Disability and Cerebral Palsy, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in carious tooth surfaces over course of the trial (time frame: The change from baseline to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.