Video Modelling and Dental Determinants on Dental Anxiety in Children (VMDDAC)

January 25, 2026 updated by: Wisnu Fadila

The Role of the "Let's Go to the Dentist!" Video Modelling and Dental Determinants on Dental Anxiety in Children

The goal of this clinical trial is to determine if video modelling reduces dental anxiety in children aged 8-12 years in Depok City. The main questions it aims to answer are: Does video modelling exposure significantly lower dental anxiety levels compared to educational video or control groups? Do family sociodemographic factors, dental health knowledge, dental visit patterns, and caries experience contribute to children's dental anxiety? Researchers compare anxiety scores of the video modelling group to the educational video group and control group (no intervention) to assess anxiety reduction effects before and after controlling for confounding factors. Children aged 8-12 years are the participants. Enumerators interview them using the Modified Dental Anxiety Scale Integrated with Facial Image Scale (MDAS+FIS) before and after each intervention, while children watch assigned videos: video modelling (twice), educational video (twice), or none (control). Enumerators record all responses. Children also undergo World Health Organization Decayed, Missing, and Filled Teeth (WHO DMFT/dmft) index dental exams plus interviews about dental knowledge, practices, caries complaints, and visit patterns. Parents complete separate interviews and surveys about family sociodemographics, their own dental knowledge and practice, and their children's dental knowledge, practices, visits, and caries experience.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Depok, West Java, Indonesia
        • Sekolah Dasar Ar-Rahman Islamic School (Ar-Rahman Islamic Elementary School)
      • Depok, West Java, Indonesia
        • Sekolah Dasar Islam Plus Darul Ulum (Darul Ulum Islamic Plus Elementary School)
      • Depok, West Java, Indonesia
        • Sekolah Dasar Negeri Cinere 1 (Cinere 1 Public Elementary School)
      • Depok, West Java, Indonesia
        • Sekolah Dasar Negeri Gandul 1 (Gandul 1 Public Elementary School)
      • Depok, West Java, Indonesia
        • Sekolah Dasar Negeri Krukut 1 (Krukut 1 Public Elementary School)
      • Depok, West Java, Indonesia
        • Sekolah Dasar Negeri Pangkalan Jati 1 (Pangkalan Jati 1 Public Elementary School)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Schoolchildren aged 8-12 years old at time of enrolment
  2. Resident of Depok City, West Java, Indonesia
  3. Currently enrolled in participating elementary school
  4. Parent/legal guardian able to provide written informed consent
  5. Child able to provide verbal assent to participate
  6. Willing and able to complete study assessments

Exclusion Criteria:

  1. Currently receiving orthodontic treatment
  2. Reside outside Depok City boundaries (verified post-assessment)
  3. Age criteria violation (outside 8-12 year range at assessment)
  4. Parent/caregiver unavailable for parent questionnaire interview
  5. Incomplete child questionnaire responses on outcome measures
  6. Institutional residence (orphanage, boarding school)
  7. Inability to provide informed consent/assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: "Let's Go to the Dentist!" Video Modelling

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:

  • Greeting dental staff calmly
  • Sitting cooperatively in dental chair
  • Responding positively to instructions
  • Maintaining calm body language during examination
  • Completing all procedures without distress
  • Leaving with positive expressions
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).
Behavioral: "Let's Brush Our Teeth!" General Dental Education Video

A 2 minutes 16 seconds educational video of a boy demonstrating correct toothbrushing technique and basic dental hygiene practices.

Content includes:

  • Proper toothbrush selection
  • Correct toothbrushing method
  • Duration of brushing
  • Interdental cleaning
  • Fluoride use
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
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.
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).
Dental Health Determinants Assessment
Time Frame: Baseline

Structured assessment of:

  • Sociodemographic factors (age, sex, grade, birth order, parental education, family income, school type)
  • Dental visit patterns (frequency past 12 months)
  • Dental health knowledge (toothbrushing frequency, time, caries cause)
  • Caries experience using World Health Organization Decayed, Missing, and Filled Teeth (WHO DMFT/dmft) index per WHO Oral Health Surveys Basic Methods, 2013.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wisnu Fadila

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Badan Riset dan Inovasi Nasional BRIN, Indonesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wisnu Fadila, DDS, MSR, Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DENT-202601.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Prohibited by Indonesian law under Personal Data Protection Act 2022.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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