Oral Health Promotion Among Preschool Children With Special Needs

Epilepsy Clinical Trial

Official title:

Effectiveness of Visual Pedagogy-assisted Tooth-brushing Training Among Preschoolers With Special Needs for Oral Health Promotion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522337
• Other study ID #: SCCC2016to2018
• Secondary ID: HKUCTR-2015
• Status: Completed
• Phase: N/A
• Start date: April 12, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: September 30, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Spectrum Disorders
• Cerebral Palsy
• Child Development Disorders, Pervasive
• Developmental Delay
• Developmental Disabilities
• Developmental Disability
• Developmental Disorders
• Disease
• Down Syndrome
• Epilepsy
• Intellectual Disability
• Learning Disorders

Intervention

Other:
• Visual pedagogy (social stories)
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
• Conventional leaflets
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)

Locations

Country	Name	City	State
China	Dental Faculty, The University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in oral hygiene status	Assessed by simplified oral hygiene index (S-OHI)	6 months, 12 months, 24 months
Secondary	Change in gingival status	Assessed by modified gingival index (MGI)	6 months, 12 months, 24 months
Secondary	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	6 months, 12 months, 24 months
Secondary	Change in children's eating habits	Questionnaires regarding children's oral health-related eating habits will be completed by parents	12 months, 24 months
Secondary	Change in children's dental-visit experience	Questionnaires regarding children's dental-visit experience will be completed by parents	24 months
Secondary	The amount of toothpaste	The weight of toothpaste dispensed by parents and/or children during tooth-brushing training	Immediately after dentists demonstrating the appropriate amount of toothpaste for children younger than 6 years old
Secondary	Toothbrush wear	Assessed by toothbrush wear index (Rawls,1989)	6 months, 12 months, 24 months