NCT07387055

Brief Summary

The goal of this observational study was to evaluate an artificial intelligence-assisted projective method for assessing dental anxiety in young children and to understand how the first child-dentist interaction affected dental anxiety. The main questions it aimed to answer were: Did the artificial intelligence-assisted projective method provide a valid and reliable assessment of dental anxiety in children aged 3 to 6 years? Did dental anxiety change after the child's first interaction with the dentist during the first dental visit? Children aged 3 to 6 years who attended their first dental visit as part of routine dental care took part. During the same visit, dental anxiety was assessed before and after the initial child-dentist interaction using picture-based dental anxiety scales and the newly developed projective method. All assessments were completed on the same day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 20, 2026

Last Update Submit

January 27, 2026

Conditions

Keywords

Dental AnxietyPediatric DentistryArtificial IntelligenceChild-Dntist Interaction

Outcome Measures

Primary Outcomes (4)

  • AI-Assisted Projective Dental Anxiety Assessment Tool Score

    Dental anxiety is assessed using an AI-Assisted projective assessment tool. The score ranges from 1 to 5, and higher scores indicate higher dental anxiety.

    Immediately before and immediately after the initial child-dentist interaction (same visit)

  • Facial Image Scale (FIS) Score

    Dental anxiety is assessed using the FIS. The score ranges from 1 to 5, and higher scores indicate higher dental anxiety.

    Immediately before and immediately after the initial child-dentist interaction (same visit)

  • Venham Picture Test (VPT) Score

    Dental anxiety is assessed using the VPT. The score ranges from 0 to 8, and higher scores indicate higher dental anxiety.

    Immediately before and immediately after the initial child-dentist interaction (same visit)

  • Raghavendra, Madhuri, and Sujata Pictorial Scale (RMS-PS) Score

    Dental anxiety is assessed using the RMS-PS. The score ranges from 1 to 5, and higher scores indicate higher dental anxiety.

    Immediately before and immediately after the initial child-dentist interaction (same visit)

Study Arms (1)

First Dental Visit Group

Children aged 3-6 years who presented for a routine dental examination, were attending their first dental visit, and met the inclusion and exclusion criteria constituted the study group.

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 3-6 years who presented for a routine dental examination to the Department of Pediatric Dentistry, Kütahya Health Sciences University, between August 2024 and November 2024.

You may qualify if:

  • The child and the parent/guardian agree to participate in the study.
  • The child's native language is Turkish.
  • The child is attending their first dental visit.
  • The child has no systemic disease.
  • The child is able to cooperate sufficiently to complete the initial dental examination.

You may not qualify if:

  • Current use of medication, a known history of allergy, or the presence of any mental or physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University, Faculty of Dentistry, Department of Pediatric Dentistry

Kütahya, Centre, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, DDS

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 4, 2026

Study Start

August 1, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations