NCT07797777

Brief Summary

This observational study evaluated whether children's dental anxiety could be identified from their speech using artificial intelligence and machine learning methods. Children aged 8-12 years attending a pediatric dentistry clinic answered a set of short, standardized questions before receiving dental treatment. Their speech was recorded, and their dental anxiety was assessed during the same session using three established measures: the Children's Fear Survey Schedule-Dental Subscale, the Modified Child Dental Anxiety Scale, and the Face Image Scale. Acoustic characteristics of the children's voices and linguistic characteristics of their spoken responses were analyzed together. Four machine learning algorithms were developed and evaluated to determine how accurately they could distinguish between children with lower and higher levels of dental anxiety. No treatment was assigned or modified as part of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

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

September 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 2, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

August 27, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

Artificial IntelligenceMachine LearningSpeech AnalysisSpeech Emotion RecognitionNatural Language ProcessingPediatric DentistryDental FearMultimodal Analysis

Outcome Measures

Primary Outcomes (1)

  • Classification Accuracy of the Multimodal Machine Learning Models

    Accuracy was defined as the proportion of participants correctly classified as having lower or higher dental anxiety. Random Forest, XGBoost, LightGBM, and CatBoost models were evaluated separately using reference classifications derived from the CFSS-DS, MCDAS, and FIS. Performance was assessed using five-fold cross-validation. Accuracy values range from 0 to 1, with higher values indicating better classification performance.

    Day 1, during the single pre-treatment assessment

Secondary Outcomes (1)

  • Sensitivity of the Multimodal Machine Learning Models

    Day 1, during the single pre-treatment assessment

Other Outcomes (1)

  • F1 Score of the Multimodal Machine Learning Models

    Day 1, during the single pre-treatment assessment

Study Arms (1)

Pediatric Dental Patients

Children aged 8-12 years attending a pediatric dentistry clinic who underwent a standardized pre-treatment speech recording and dental anxiety assessment during a single study visit. No dental treatment was assigned, changed, or delayed as part of the study.

Diagnostic Test: Multimodal Speech-Based Dental Anxiety Assessment

Interventions

Participants completed a standardized 1-3-minute speech recording before dental treatment. Acoustic and linguistic characteristics of their speech were analyzed using artificial intelligence methods. During the same session, dental anxiety was assessed using the Children's Fear Survey Schedule-Dental Subscale, the Modified Child Dental Anxiety Scale, and the Face Image Scale. The assessment was conducted for research purposes and did not alter the participants' planned dental care.

Pediatric Dental Patients

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

he study population consisted of children aged 8-12 years who attended the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry for routine dental care between September 2025 and February 2026. Eligible children completed a standardized speech recording and three dental anxiety assessments during a single visit before dental treatment. Children with both lower and higher levels of dental anxiety were included. Participation did not alter or delay the dental care planned for any child.

You may qualify if:

  • Children aged 8-12 years
  • Attendance at the Department of Pediatric Dentistry, Marmara University -Faculty of Dentistry
  • Native Turkish speaker
  • Age-appropriate neuropsychological development
  • Ability to communicate, cooperate in the clinical setting, and understand and follow the study instructions
  • No chronic or systemic condition affecting speech production, respiratory function, or cognitive processes
  • Written informed consent provided by a parent or legal guardian

You may not qualify if:

  • Neurological, hearing, speech, or language disorder that could affect clinical communication or study assessments
  • Suspected or diagnosed neurodevelopmental disorder, including autism spectrum disorder or attention-deficit/hyperactivity disorder
  • Native language other than Turkish
  • Active pathology or history of surgery that could affect voice or speech quality, including resonance or phonation
  • Inability to provide sufficient verbal data, such as consistently giving single-word responses or leaving multiple questions unanswered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Study Officials

  • Gizem Akova

    Marmara University Faculty Of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

September 10, 2025

Primary Completion

February 10, 2026

Study Completion

April 10, 2026

Last Updated

September 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations