- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522337
Oral Health Promotion Among Preschool Children With Special Needs
Effectiveness of Visual Pedagogy-assisted Tooth-brushing Training Among Preschoolers With Special Needs for Oral Health Promotion
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hong Kong
-
Hong Kong, Hong Kong, China
- Dental Faculty, The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Other Names:
|
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.
|
Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
The change from baseline to 24 months
|
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)
|
The change from baseline to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in oral hygiene status
Time Frame: 6 months, 12 months, 24 months
|
Assessed by simplified oral hygiene index (S-OHI)
|
6 months, 12 months, 24 months
|
Change in gingival status
Time Frame: 6 months, 12 months, 24 months
|
Assessed by modified gingival index (MGI)
|
6 months, 12 months, 24 months
|
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
|
6 months, 12 months, 24 months
|
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
|
12 months, 24 months
|
Change in children's dental-visit experience
Time Frame: 24 months
|
Questionnaires regarding children's dental-visit experience will be completed by parents
|
24 months
|
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
|
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
|
Assessed by toothbrush wear index (Rawls,1989)
|
6 months, 12 months, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hai Ming Wong, PhD, Dental Faculty, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Abnormalities, Multiple
- Chromosome Disorders
- Communication Disorders
- Cerebral Palsy
- Disease
- Autism Spectrum Disorder
- Down Syndrome
- Developmental Disabilities
- Intellectual Disability
- Learning Disabilities
Other Study ID Numbers
- SCCC2016to2018
- HKUCTR-2015 (REGISTRY: HKU Clinical Trials Registry (HKUCTR))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epilepsy
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on Conventional leaflets
-
Aga Khan UniversityNot yet recruitingAnxiety Disorders | Mental Disorder in Adolescence | Depression in AdolescencePakistan
-
Ministry of Health, MalaysiaUniversiti Sains MalaysiaActive, not recruitingCardiovascular Diseases | Stroke | Risk Factor, CardiovascularMalaysia
-
University Hospital, GrenobleCompletedGastroenteritis | PharyngitisFrance
-
Horselvarden Region OstergotlandCompletedHearing ImpairmentSweden
-
China Medical University HospitalRecruitingRenal Replacement Therapy | End-stage Renal Disease | Decision Aid | Decision-makingTaiwan
-
Ministry of Education, MalaysiaCompletedDental Caries in Children
-
Ningbo No. 1 HospitalRecruitingCovid19 | Knowledge, Attitudes, PracticeChina
-
University of AlbertaPfizerActive, not recruiting
-
University of AlbertaCanadian Institutes of Health Research (CIHR)Completed
-
Central Hospital, Nancy, FranceUniversity of LorraineCompletedAntibiotic PrescriptionFrance