- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365774
Video Modelling and Dental Determinants on Dental Anxiety in Children (VMDDAC)
The Role of the "Let's Go to the Dentist!" Video Modelling and Dental Determinants on Dental Anxiety in Children
Study Overview
Status
Conditions
Detailed Description
Dental problems affect children worldwide due to sociodemographic factors, high sugar intake, limited access, urbanization, and lifestyle changes, particularly in low and middle income countries. Indonesia's Riset Kesehatan Dasar/Basic Health Research (Riskesdas) 2018 documented 67.3% prevalence among children aged 5-9 years and 55.6% among 10-14 years with only 14.6% and 9.4% accessing professional care respectively, highlighting dental anxiety as a key mediator alongside established risk factors. Family and school environments critically shape children's dental health attitudes, supporting early promotive preventive interventions.
This study tests video modeling, a safe, scalable nonpharmacologic approach leveraging observational learning, against placebo and control conditions. The experimental intervention demonstrates sequential prosocial behaviors through a child model, including calm greeting of dental staff, positive responses to instructions, procedural tolerance without distress, and satisfied departure.
The design evaluates repeated exposure effects, specifically two viewings with 30 minute interval, within urban Depok elementary schools representing diverse socioeconomic contexts. Parental interviews provide additional perspectives alongside quantitative outcomes on dental health determinants, informing national policy translation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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West Java
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Depok, West Java, Indonesia
- Sekolah Dasar Ar-Rahman Islamic School (Ar-Rahman Islamic Elementary School)
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Depok, West Java, Indonesia
- Sekolah Dasar Islam Plus Darul Ulum (Darul Ulum Islamic Plus Elementary School)
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Depok, West Java, Indonesia
- Sekolah Dasar Negeri Cinere 1 (Cinere 1 Public Elementary School)
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Depok, West Java, Indonesia
- Sekolah Dasar Negeri Gandul 1 (Gandul 1 Public Elementary School)
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Depok, West Java, Indonesia
- Sekolah Dasar Negeri Krukut 1 (Krukut 1 Public Elementary School)
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Depok, West Java, Indonesia
- Sekolah Dasar Negeri Pangkalan Jati 1 (Pangkalan Jati 1 Public Elementary School)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Schoolchildren aged 8-12 years old at time of enrolment
- Resident of Depok City, West Java, Indonesia
- Currently enrolled in participating elementary school
- Parent/legal guardian able to provide written informed consent
- Child able to provide verbal assent to participate
- Willing and able to complete study assessments
Exclusion Criteria:
- Currently receiving orthodontic treatment
- Reside outside Depok City boundaries (verified post-assessment)
- Age criteria violation (outside 8-12 year range at assessment)
- Parent/caregiver unavailable for parent questionnaire interview
- Incomplete child questionnaire responses on outcome measures
- Institutional residence (orphanage, boarding school)
- Inability to provide informed consent/assent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video Modelling
Children complete baseline Modified Dental Anxiety Scale Integrated with Facial Image Scale assessment (MDAS+FIS).
They then view the "Let's Go to the Dentist!" video (2 minutes 37 seconds).
MDAS+FIS is assessed immediately afterward (posttest 1).
After a 30-minute wait period, children view the same video again.
MDAS+FIS is assessed immediately afterward (posttest 2).
|
A 2 minutes 37 seconds video depicting a girl demonstrating calm and cooperative behaviour throughout a complete dental visit, from arrival through discharge. Content includes:
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Placebo Comparator: Educational Video
Children complete baseline Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS) assessment.
They then view the "Let's Brush Our Teeth!" video (2 minutes 16 seconds).
MDAS+FIS is assessed immediately afterward (posttest 1).
After a 30-minute wait period, children view the same video again.
MDAS+FIS is assessed immediately afterward (posttest 2).
|
A 2 minutes 16 seconds educational video of a boy demonstrating correct toothbrushing technique and basic dental hygiene practices. Content includes:
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No Intervention: Control
Children complete baseline Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS) assessment.
They wait 30 minutes with no video intervention.
MDAS+FIS is assessed at matching time points (posttest 1 equivalent and posttest 2 equivalent).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental Anxiety Level
Time Frame: Baseline to post-intervention 1 (immediately after first video exposure), then to post-intervention 2 (immediately after second video exposure, 30 minutes after first post-assessment).
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Change in dental anxiety scores assessed by the Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS).
The MDAS+FIS consists of 5 items scored from 1 to 5, giving a total score range of 5 (lowest anxiety) to 25 (highest anxiety), and higher scores indicate worse (greater) dental anxiety levels.
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Baseline to post-intervention 1 (immediately after first video exposure), then to post-intervention 2 (immediately after second video exposure, 30 minutes after first post-assessment).
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Dental Health Determinants Assessment
Time Frame: Baseline
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Structured assessment of:
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wisnu Fadila, DDS, MSR, Universitas Padjadjaran
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
Keywords
Other Study ID Numbers
- DENT-202601.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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