NCT07596771

Brief Summary

The goal of this clinical trial is to evaluate the overall effect of an artificial intelligence-generated, instrument-specific animated video series compared with the conventional Tell-Show-Do (TSD) technique on dental anxiety in children aged 4 to 8 years. The study will also investigate whether the anxiety-reducing effect differs according to the dental instrument introduced. Researchers will compare the animated video series with the conventional Tell-Show-Do technique across four dental instruments: dental mirror, dental probe, micromotor handpiece, and saliva ejector. Participants will be randomly assigned to one of the study groups. Children will either watch an instrument-specific animated educational video or receive the Tell-Show-Do technique related to a specific dental instrument. Dental anxiety levels will be evaluated using the Facial Image Scale (FIS), Venham Picture Test (VPT) and Modified Child Dental Anxiety Scale-Faces version (MCDASf), together with pulse rate and oxygen saturation levels, before and after the application procedure.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress71%
Feb 2026Jun 2026

Study Start

First participant enrolled

February 17, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Animated Educational VideoDental AnxietyTell-Show-DoArtificial IntelligencePediatric Dentistry

Outcome Measures

Primary Outcomes (2)

  • Venham's Picture Test (VPT)

    An eight-item pictorial anxiety measure requiring children to select the image (anxious or non-anxious figure) that best represents their feelings (score range 0-8).

    Baseline (T0) and immediately post-intervention (T1)

  • Facial Image Scale (FIS)

    A five-item pictorial self-report scale depicting faces ranging from very happy (1) to very unhappy (5), validated for use in children aged ≥ 4 years with limited literacy.

    Baseline (T0) and immediately post-intervention (T1)

Secondary Outcomes (3)

  • Modified Child Dental Anxiety Scale - Faces Version (MCDASf)

    Baseline (T0) and immediately post-intervention (T1)

  • Heart Rate (HR)

    Baseline (T0) and immediately post-intervention (T1)

  • Peripheral Oxygen Saturation (SpO₂)

    Baseline (T0) and immediately post-intervention (T1)

Study Arms (8)

Animated Series - Dental Mirror

EXPERIMENTAL

Children in this arm viewed a single episode of the AI-generated animated video series (\~60 seconds) corresponding to the dental mirror, presented on a 10-inch tablet at 60 dB SPL in the dental waiting area prior to clinical examination. The episode features a recurring maternal character and anthropomorphic dental germ characters that hide among tooth surfaces and are revealed and removed by the dental mirror.

Behavioral: AI-Generated Animated Video Series

Tell-Show-Do - Dental Mirror

ACTIVE COMPARATOR

Children in this arm received the standard Tell-Show-Do technique (\~4 minutes) applied specifically to the dental mirror, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).

Behavioral: Tell-Show-Do (TSD) Technique

Animated Series - Dental Probe

EXPERIMENTAL

Children in this arm viewed a single episode of the AI-generated animated video series (\~60 seconds) corresponding to the dental probe. The episode features a recurring maternal character and anthropomorphic dental germ characters that jump between teeth and become wedged in interproximal spaces, then are dislodged and removed by the dental probe.

Behavioral: AI-Generated Animated Video Series

Tell-Show-Do - Dental Probe

ACTIVE COMPARATOR

Children in this arm received the standard Tell-Show-Do technique (\~4 minutes) applied specifically to the dental probe, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).

Behavioral: Tell-Show-Do (TSD) Technique

Animated Series - Micromotor Handpiece

EXPERIMENTAL

Children in this arm viewed a single episode of the AI-generated animated video series (\~60 seconds) corresponding to the micromotor handpiece. The episode features a recurring maternal character and anthropomorphic dental germ characters that eat and rest on a tooth surface, then are tickled and removed by the micromotor handpiece.

Behavioral: AI-Generated Animated Video Series

Tell-Show-Do - Micromotor Handpiece

ACTIVE COMPARATOR

Children in this arm received the standard Tell-Show-Do technique (\~4 minutes) applied specifically to the micromotor handpiece, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).

Behavioral: Tell-Show-Do (TSD) Technique

Animated Series - Saliva Ejector

EXPERIMENTAL

Children in this arm viewed a single episode of the AI-generated animated video series (\~60 seconds) corresponding to the saliva ejector. The episode features a recurring maternal character and anthropomorphic dental germ characters that flood the mouth with water and swim freely, then are eliminated by the suction of the saliva ejector.

Behavioral: AI-Generated Animated Video Series

Tell-Show-Do - Saliva Ejector

ACTIVE COMPARATOR

Children in this arm received the standard Tell-Show-Do technique (\~4 minutes) applied specifically to the saliva ejector, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).

Behavioral: Tell-Show-Do (TSD) Technique

Interventions

An original four-episode animated video series produced using AI-assisted animation tools. Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument. Each child viewed only the single episode corresponding to the instrument assigned to their group.

Animated Series - Dental MirrorAnimated Series - Dental ProbeAnimated Series - Micromotor HandpieceAnimated Series - Saliva Ejector

The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do). Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.

Tell-Show-Do - Dental MirrorTell-Show-Do - Dental ProbeTell-Show-Do - Micromotor HandpieceTell-Show-Do - Saliva Ejector

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 4-8 years
  • Frankl Behaviour Rating Scale score of 3 or 4 (positive or definitely positive) at initial assessment
  • No previous restorative or surgical dental treatment
  • ASA physical status classification I or II
  • Ability to communicate in Turkish
  • Written informed consent from the parent or legal guardian

You may not qualify if:

  • Confirmed neurodevelopmental disorder (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder)
  • Clinically significant visual or hearing impairment
  • Prior exposure to formal behaviour management conditioning programmes
  • Requirement for emergency dental care at the study appointment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University Faculty of Dentistry

Alanya, Antalya, 07425, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Hexosaminidase AMethods

Intervention Hierarchy (Ancestors)

beta-N-AcetylhexosaminidasesHexosaminidasesGlycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Participants will be randomized into factorial groups based on behavioral management technique and dental instrument exposure.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

February 17, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly due to ethical considerations related to pediatric participants and institutional data protection policies. De-identified aggregate data may be reported in publications.

Locations