Epilepsy Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04595513 -
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
|
Phase 1/Phase 2 | |
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05552924 -
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
|
N/A | |
Terminated |
NCT01668654 -
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
|
Phase 3 | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT03994718 -
Creative Arts II Study
|
N/A | |
Recruiting |
NCT04076449 -
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
|
||
Completed |
NCT00782249 -
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
Active, not recruiting |
NCT06034353 -
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
|
N/A | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
Not yet recruiting |
NCT05559060 -
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
|
||
Completed |
NCT02646631 -
Behavioral and Educational Tools to Improve Epilepsy Care
|
N/A | |
Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
Completed |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
Recruiting |
NCT02539134 -
TAK-935 Multiple Rising Dose Study in Healthy Participants
|
Phase 1 | |
Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A | |
Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A |