NCT07365774

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 16, 2026

Last Update Submit

January 25, 2026

Conditions

Keywords

Dental AnxietyVideo ModellingChildrenCaries ExperienceDental VisitsOral Health KnowledgeSociodemographic FactorsModified Dental Anxiety Scale

Outcome Measures

Primary Outcomes (2)

  • Dental Anxiety Level

    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

    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

Study Arms (3)

Video Modelling

EXPERIMENTAL

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

Educational Video

PLACEBO COMPARATOR

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

Control

NO INTERVENTION

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).

Interventions

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

Video Modelling

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

Educational Video

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sekolah Dasar Ar-Rahman Islamic School (Ar-Rahman Islamic Elementary School)

Depok, West Java, Indonesia

Location

Sekolah Dasar Islam Plus Darul Ulum (Darul Ulum Islamic Plus Elementary School)

Depok, West Java, Indonesia

Location

Sekolah Dasar Negeri Cinere 1 (Cinere 1 Public Elementary School)

Depok, West Java, Indonesia

Location

Sekolah Dasar Negeri Gandul 1 (Gandul 1 Public Elementary School)

Depok, West Java, Indonesia

Location

Sekolah Dasar Negeri Krukut 1 (Krukut 1 Public Elementary School)

Depok, West Java, Indonesia

Location

Sekolah Dasar Negeri Pangkalan Jati 1 (Pangkalan Jati 1 Public Elementary School)

Depok, West Java, Indonesia

Location

Study Officials

  • Wisnu Fadila, DDS, MSR

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

October 26, 2024

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Prohibited by Indonesian law under Personal Data Protection Act 2022.

Locations