NCT07449884

Brief Summary

This randomized clinical trial aims to compare two behavior guidance techniques used to reduce anxiety in children during local anesthesia injections in dental treatment. The study evaluates the traditional Tell-Show-Do (TSD) technique versus an artificial intelligence (AI)-driven, avatar-based video method called the "Mini Dentist." Children aged 5 to 7 years who require local anesthesia for routine dental treatment will be randomly assigned to one of two groups. The control group will receive the conventional Tell-Show-Do explanation from the pediatric dentist. The experimental group will watch a short animated video featuring an AI-generated avatar that explains and demonstrates the procedure in a child-friendly manner before the injection. Anxiety and behavior will be assessed using heart rate monitoring, behavioral observation (FLACC scale), and a self-reported pain scale (Wong-Baker FACES). The goal is to determine whether the AI-based method improves cooperation and reduces anxiety compared to the traditional approach. Participation is voluntary, and all procedures follow ethical research standards.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
13mo left

Started Feb 2026

Typical duration for not_applicable anxiety

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

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Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026May 2027

Study Start

First participant enrolled

February 16, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

March 30, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 26, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

Artificial intelligenceChild behaviorDental anxietyLocal anesthesia.Randomized Controlled trial

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response

    Heart rate will be measured using a pulse oximeter before and during local anesthesia administration to assess physiological anxiety response.

    Immediately before and during local anesthesia administration (single visit)

Secondary Outcomes (2)

  • Pain Perception During Local Anesthesia Administration

    Immediately after local anesthesia administration (same visit)

  • Child Behavioral Response During Local Anesthesia

    During local anesthesia administration (same visit)

Study Arms (2)

AI Avatar Video Group

EXPERIMENTAL

Participants in this group will watch an artificial intelligence-driven avatar-based video explaining the local anesthesia procedure before receiving the injection. The video presents the procedure in a child-friendly manner to reduce anxiety and improve cooperation during treatment.

Behavioral: AI Avatar-Based video

Tell-Show-Do Group

ACTIVE COMPARATOR

Participants in this group will receive behavior management using the conventional Tell-Show-Do technique before administration of local anesthesia. The dentist will verbally explain, demonstrate, and then perform the procedure according to standard pediatric dental practice.

Behavioral: Tell-Show-Do Technique

Interventions

A pre-recorded artificial intelligence-driven avatar-based educational video shown to children prior to administration of local anesthesia. The video explains the injection procedure in simple, age-appropriate language to reduce dental anxiety and improve cooperation.

AI Avatar Video Group

A conventional behavior management technique used in pediatric dentistry in which the dentist tells the child about the procedure, shows the instruments in a non-threatening way, and then performs the treatment. This method aims to reduce anxiety and improve cooperation during local anesthesia administration.

Tell-Show-Do Group

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5 to 7 years
  • Medically healthy (ASA I)
  • Cooperative behavior during dental examination
  • No known allergy to local anesthetics
  • Require non-urgent dental treatment under local anesthesia
  • First-time experience receiving local anesthesia
  • Able to understand and communicate

You may not qualify if:

  • History of epilepsy
  • Diagnosed anxiety or behavioral disorders
  • Cognitive or developmental delay
  • Hearing or visual impairment
  • Previous experience with dental anesthesia
  • Require inferior alveolar nerve block anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Joseph University of Beirut- Pediatric Dentistry clinic

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersChild Behavior

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Central Study Contacts

Rita Melekian, Pediatric dentistry resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

February 16, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

March 30, 2026

Record last verified: 2026-02

Locations