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Caries, DentalNCT07133919

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

A study testing AI-Assisted Child-Friendly Communication and Traditional Behavior Management Techniques in people with Caries, Dental and Local Anesthesia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 12 yearsHealthy volunteers can take part
What is being tested?
AI-Assisted Child-Friendly Communication and Traditional Behavior Management Techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2025to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Burak Çarıkçıoğlu, Associate Professor contact

00905054956091

carikcioglub@gmail.com

Hilal ÖZTÜRK, Research Assistant contact

00905312591404

hilalozturk98@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Canakkale Onsekiz Mart University

    Çanakkale, Kepez, 17100

    Faculty of Dentistry, 2862180018, dishekimliği@comu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Traditional Behavior Management Techniques and AI-Assisted Child-Friendly Communication on Dental Anxiety in Pediatric Dental Anesthesia Applications

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.

Read the detailed description

Successful pediatric dental treatment depends on effective therapeutic communication and tailored behavior management strategies based on the child's needs and the clinician's experience. Local anesthesia often induces dental anxiety, elevated physiological stress, and increased pain perception, which can impair treatment outcomes and contribute to dental phobia. Although traditional techniques like Tell-Show-Do and positive reinforcement are commonly used, their effectiveness may be limited in some children.

The integration of artificial intelligence (AI) and digital technologies has enabled personalized communication strategies adapted to children's cognitive and psychosocial development. AI tools such as ChatGPT act as distraction methods to reduce anxiety and stress during dental procedures. Furthermore, AI-enhanced audiovisual devices like virtual reality (VR) headsets have been shown to decrease dental anxiety, physiological stress responses, and pain perception in pediatric patients.

This study will be conducted with healthy children aged 7 to 12 who require inferior alveolar nerve block (IANB) anesthesia and have Frankl Behavior Rating Scale scores of 2 (negative) or 3 (positive). Demographic and dental data such as age, gender, and treated tooth numbers will be recorded prior to the procedure.

Participants will be randomly assigned into two groups: Group 1 (Control) and Group 2 (ChatGPT).

Control Group (Group 1):

Before local anesthesia, traditional behavior management techniques selected by the pediatric dentist based on clinical observation and experience will be applied. These include modified Tell-Show-Do (limiting exposure to potentially anxiety-provoking stimuli like dental syringes), voice control, and positive reinforcement. Explanations regarding the anesthesia procedure will be delivered verbally, tailored to the child's cognitive level and understanding capacity.

For example (From the investigators to participants):

"Hello, welcome! I see you are a bit worried, but that's very normal. People sometimes get scared of things they don't know, right? Now, please lie back comfortably, and I will tell you what are we (investigators) going to do. First, I will spray a magic sleepy water (or cold spray/warm water) on your (participants')tooth. This will make your tooth numb, so you won't feel anything. You might feel a tiny little mosquito touch, but it will pass quickly. Then your tooth will be asleep, and we (investigators) will do our work comfortably. While I'm making your tooth sleep, just lean back and think of happy memories." Following this, traditional behavior management techniques such as positive reinforcement and voice control will accompany the topical anesthesia application and then the local anesthesia procedure. The total procedure duration will not exceed 5 minutes.

Experimental Group (Group 2):

Given that cognitive abilities, language comprehension, and psychosocial needs vary by developmental stage, AI-supported communication content will be structured accordingly. Using ChatGPT, age- and gender-specific voice recordings explaining the local anesthesia procedure will be created considering developmental characteristics of children aged 7-12. Additionally, a one-minute child-friendly, anxiety-reducing story without anxiety-provoking words will be generated to be played during the anesthesia application to enhance patient cooperation and reduce anxiety.

Commands given to the AI were:

"I am about to apply local anesthesia to a [age]-year-old [girl/boy] patient with high anxiety levels. Please explain the procedure steps in a child-friendly, simple, and reassuring manner avoiding words like 'pain' and 'needle', considering developmental characteristics, age-appropriate interests, and gender-specific tendencies."

"During the anesthesia application, please tell a one-minute calming and distracting story suitable for a [age]-year-old [girl/boy], without anxiety-provoking expressions, tailored to their developmental stage and interests." Before anesthesia, children in this group will listen to the AI-generated voice explanation, and during anesthesia, the AI-generated story will be played.

Assessment criteria:

Physiological responses including heart rate and oxygen saturation will be objectively measured using a pulse oximeter (LifeNet Fingertip Pulse Oximeter; Model: KE-6004) attached to the finger before, during, and after anesthesia, recording the highest values for each phase. Subjective anxiety will be evaluated with the Venham Picture Test (VPT) and Facial Image Scale (FIS) before and after anesthesia. Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale at the end of anesthesia. Dental anxiety will be evaluated before and after anesthesia using the Modified Child Dental Anxiety Scale - Faces Version (MCDAS-f). Children's behavior during anesthesia will be recorded using the Modified Houpt Behavior Scale based on the clinician's observations. Cooperation levels will be assessed with the Frankl Behavior Rating Scale before and after anesthesia. Finally, to evaluate perceptions and attitudes toward AI-assisted communication, a 4-item child questionnaire and a 2-item parent questionnaire using 5-point Likert scales will be administered after treatment.

This study aims to compare the effectiveness of traditional behavior management techniques versus AI-assisted child-friendly communication in managing dental anxiety, physiological stress, and pain perception during local anesthesia in children, potentially contributing to innovative, evidence-based approaches in pediatric dental care.

Being tested
AI-Assisted Child-Friendly Communication, Traditional Behavior Management Techniques
Keywords
dental anesthesia, dental anxiety, pediatric dentistry, pediatric patients, inferior alveolar nerve block
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-Assisted Child-Friendly CommunicationBehavioural

    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.

  • Traditional Behavior Management TechniquesBehavioural

    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.

Study groups in NCT07133919
Study groupRoleWhat they receive
Arm 1: Traditional Behavior Management (Control Group)OtherNot described
Receives: Behavioral: Traditional Behavior Management Techniques
Arm 2: AI-Assisted Child-Friendly CommunicationExperimentalNot described
Receives: Behavioral: AI-Assisted Child-Friendly Communication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulse

    Throughout the session, pulse levels were recorded using a pulse oximeter at

    three points: before, during, and after the local anesthesia.

    Measured: 5 minutes

  2. Oxygen Saturation

    Throughout the session, saturation levels were recorded using a pulse oximeter

    at three points: before, during, and after the local anesthesia.

    Measured: 5 minutes

Secondary outcomes (6)
  1. Change in Facial Image Scale (FIS)" score

    FIS assesses anxiety in children using five facial expressions ranging from very happy to very unhappy. Children select the face that best represents their feelings at that moment. Scores range from 1 to 5; higher scores indicate higher anxiety levels.

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

  2. Wong-Baker Faces Pain Rating Scale

    This visual self-report tool uses six faces to represent increasing levels of pain. Children choose the face that best matches their pain level. Scores range from 0 (no pain) to 10 (worst pain).

    Measured: within 5 minutes after completion of local anesthesia procedure.

  3. Modified Houpt Behavior Rating Scale score

    This scale evaluates movement, crying, and overall behavior during treatment, each rated from 1 to 4. Higher total scores indicate lower cooperation and increased treatment difficulty.

    Measured: During treatment

  4. Frankl Behavior Rating Scale

    This 4-point behavioral rating scale assesses cooperation during dental treatment. Scores: 1 (definitely negative), 2 (negative), 3 (positive), 4 (definitely positive). Higher scores reflect more cooperative behavior.

    Measured: During treatment

  5. Change in "Venham Picture Test (VPT)" score

    VPT consists of 8 pairs of drawings showing children with contrasting emotional expressions. The child selects the picture they relate to most. One point is given for each anxious image selected, yielding a total score from 0 to 8; higher scores indicate more anxiety.

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

  6. Change in "Modified Child Dental Anxiety Scale - faces version (MCDAS-f)"

    MCDAS-f evaluates dental anxiety using 8 items related to specific dental procedures. Each item is rated on a 5-point Likert scale using facial images, with scores from 1 (not anxious) to 5 (very anxious). Total score ranges from 8 to 40; higher scores indicate greater anxiety.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start15 Oct 2025
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133919
Sponsor's protocol ID
CanakkaleOMU2
Status last verified
Dec 2025
First submitted
5 Aug 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AI-Assisted Child-Friendly Communication and Traditional Behavior Management Techniques in people with Caries, Dental and Local Anesthesia, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Burak Çarıkçıoğlu, Associate Professor (00905054956091, carikcioglub@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulse (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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