Effect of AI-Supported Child-Friendly Communication on Dental Anxiety in Pediatric Patients

NCT07133919 | Recruiting

• 1 other identifier: CanakkaleOMU2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effects of traditional behavior management techniques and AI-assisted child-friendly communication on dental anxiety, physiological stress, and pain perception during local anesthesia in healthy children aged 6-12. The aim is to evaluate the effectiveness of AI-supported communication tools in reducing anxiety and improving comfort in pediatric dental treatments, potentially enhancing clinical outcomes and advancing technology use in pediatric dentistry.

Conditions

Caries, Dental; Local Anesthesia; Inferior Alveolar Nerve Block; Dental Anxiety

Keywords

dental anesthesia; dental anxiety; pediatric dentistry; pediatric patients; inferior alveolar nerve block

Outcome Measures

Primary Outcomes (2)

• Pulse

  Throughout the session, pulse levels were recorded using a pulse oximeter at three points: before, during, and after the local anesthesia.

  5 minutes

• Oxygen Saturation

  Throughout the session, saturation levels were recorded using a pulse oximeter at three points: before, during, and after the local anesthesia.

  5 minutes

Secondary Outcomes (6)

• Change in Facial Image Scale (FIS)" score

  Within 5 minutes before local anesthesia administration, and within 5 minutes after completion of local anesthesia procedure.

• Wong-Baker Faces Pain Rating Scale

  within 5 minutes after completion of local anesthesia procedure.

• Modified Houpt Behavior Rating Scale score

  During treatment

• Frankl Behavior Rating Scale

  During treatment

• Change in "Venham Picture Test (VPT)" score

  Within 5 minutes before local anesthesia administration, and within 5 minutes after completion of local anesthesia procedure.

Other Outcomes (1)

• Perceptions and attitudes of children and parents toward AI-assisted communication

  within 5 minutes after completion of local anesthesia procedure.

Study Arms (2)

Arm 1: Traditional Behavior Management (Control Group)

OTHER

Behavioral: Traditional Behavior Management Techniques

Arm 2: AI-Assisted Child-Friendly Communication

EXPERIMENTAL

Behavioral: AI-Assisted Child-Friendly Communication

Interventions

AI-Assisted Child-Friendly Communication BEHAVIORAL

AI-assisted communication tailored to the developmental stage, age, and gender of children aged 7-12 will be used. Using ChatGPT, voice recordings explaining the local anesthesia process in a child-friendly and reassuring way-avoiding anxiety-provoking terms such as "pain" and "needle"-will be prepared. Additionally, a one-minute calming and distracting story will be generated to be played during anesthesia to reduce anxiety and improve cooperation. Children will listen to the AI-generated explanation before the procedure and the story during anesthesia.

Arm 2: AI-Assisted Child-Friendly Communication

Traditional Behavior Management Techniques BEHAVIORAL

Before local anesthesia, traditional behavior management techniques will be applied by the pediatric dentist based on clinical experience. These include a modified Tell-Show-Do approach (avoiding direct exposure to anxiety-provoking items like dental syringes), voice control, and positive reinforcement. The anesthesia procedure will be explained verbally in an age-appropriate and reassuring manner, for example by describing the use of a "magic sleepy spray" to numb the tooth. Following this, topical anesthesia and then local anesthesia will be administered. The total procedure will not exceed 5 minutes.

Arm 1: Traditional Behavior Management (Control Group)

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children volunteers and their parents/legal guardians who have read and signed the informed consent form and agreed to participate in the study
• Systemically healthy children aged 6-12 years in the mixed dentition period
• Children requiring restorative dental procedures (including pulpotomy, pulp capping, or composite restorations) on mandibular teeth under inferior alveolar nerve block local anesthesia
• Children who are attending their first dental visit and demonstrate behavior rated as 2 (negative) or 3 (positive) according to the Frankl Behavior Rating Scale (Categories: 1 - definitely negative; 2 - negative; 3 - positive; 4 - definitely positive) Behaviors will be categorized as positive (+) or negative (-) based on the Frankl Behavior Rating Scale (Wright's modification)
• Children receiving local anesthesia for the first time

You may not qualify if:

• Children volunteers and their parents/legal guardians who read the informed consent form but declined to participate in the study
• Children with systemic diseases requiring continuous medication
• Children with mental or cognitive impairments, as well as those with visual or hearing disabilities
• Children who, after oral prophylaxis at the first visit, exhibit "definitely negative" (Frankl 1) or "definitely positive" (Frankl 4) behavior according to the Frankl Behavior Rating Scale
• Children with previous experience of local anesthesia

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, Kepez, 17100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Burak Çarıkçıoğlu, Associate Professor

CONTACT

00905054956091; carikcioglub@gmail.com

Hilal ÖZTÜRK, Research Assistant

CONTACT

00905312591404; hilalozturk98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 21, 2025
• Study Start: October 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)