AI-Generated Personalized Story Book to Improve Patient Behaviour

NCT07778134 | Recruiting

• 1 other identifier: TDH-2026-4010
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Dental anxiety and uncooperative behavior frequently interfere with the successful delivery of dental treatment in children and may increase the need for pharmacological behavior management. Storytelling is a widely used non-pharmacological behavior guidance technique that can improve participants' familiarity with the dental environment and enhance cooperation. Recent advances in artificial intelligence (AI) enable the development of personalized storybooks tailored to each participant's individual characteristics and preferences, which may improve engagement with behavior guidance interventions. This randomized controlled trial aims to compare the effectiveness of three behavior guidance approaches in pediatric participants receiving dental treatment: (1) an AI-generated personalized dental storybook, (2) a standard dental storybook, and (3) standard behavior guidance alone. Eligible participants will be randomly allocated to one of the three study groups. The AI-generated storybook will be individually designed according to each participant's characteristics and interests, whereas the standard storybook will contain the same dental theme without personalization. Participants in the control group will receive routine non-pharmacological behavior guidance used in pediatric dental practice. Behavioral cooperation, dental anxiety, treatment acceptance, and other prespecified outcomes will be assessed using validated measurement tools before and during dental treatment.

Conditions

Dental Anxiety in Children; Behavior Management; Pediatric Dental Anxiety

Keywords

pediatric dentistry; dental anxiety; behavior management; artificial intelligence; personalized storytelling; randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Facial Image Scale (FIS) score - child reported

  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.

  Baseline (pre-intervention) and post-procedure at Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4); each session lasting approximately 30-45 minutes

• Facial Image Scale (FIS) score - clinician reported

  The clinician-reported Facial Image Scale (FIS) assesses the child's anxiety level based on five facial expressions ranging from very happy to very unhappy. The clinician selects the facial expression that best represents the child's observed emotional state. Scores range from 1 to 5, with higher scores indicating higher levels of anxiety.

  Baseline (pre-intervention) and post-procedure at Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4); each session lasting approximately 30-45 minutes

• Venham Picture Test (VPT) score

  VPT consists of 8 pairs of drawings showing children with contrasting emotional expressions. The child is asked to select the image that most closely reflects their current emotional state from each pair. One point is assigned for each anxiety-related image selected, resulting in a total score ranging from 0 to 8. Higher scores indicate more dental anxiety.

  Baseline (pre-intervention) and post-procedure at Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4); each session lasting approximately 30-45 minutes

• Pulse

  This measurement will be performed to provide an objective assessment of the child's physiological response to dental treatment-related anxiety.

  Baseline (pre-intervention) and post-procedure at Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4); each session lasting approximately 30-45 minutes

• Oxygen Saturation

  This measurement will be performed to provide an objective assessment of the child's physiological response to dental treatment-related anxiety.

  Baseline (pre-intervention) and post-procedure at Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4); each session lasting approximately 30-45 minutes

• Venham Clinical Cooperation Scale (VCCS) score

  The Venham Clinical Cooperation Scale (VCCS) is a six-point clinician-rated scale used to assess a child's level of cooperation during dental treatment. Scores range from 0 to 5, with 0 indicating good cooperation and 5 indicating severe uncooperative behavior. The score reflects the child's overall behavioral response and level of cooperation throughout the dental visit, with higher scores indicating poorer cooperation.

  At the end of each session: Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4)

Secondary Outcomes (2)

• Plaque Index (Silness and Löe)

  Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)

• Modified Gingival Index

  Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)

Study Arms (3)

Control Group

ACTIVE COMPARATOR

The Venham Picture Test (VPT; child-reported) and Facial Image Scale (FIS; child- and clinician-reported) will be administered. Heart rate and oxygen saturation will be measured using a pulse oximeter and recorded as baseline physiological parameters. Participants in the control group will receive the same procedures using only conventional behavior guidance techniques, including verbal communication and the tell-show-do technique, applied sequentially. At each treatment visit, the overall visit score determined by the clinician will be recorded using the Venham Clinical Cooperation Scale (VCCS).

Behavioral: Standard Behavior Guidance

Standard dental storybook

ACTIVE COMPARATOR

The Venham Picture Test (VPT; child-reported) and Facial Image Scale (FIS; child- and clinician-reported) will be administered. Heart rate and oxygen saturation will be measured using a pulse oximeter and recorded as baseline physiological parameters. The storybook entitled "The Dentist" will be read together with the clinician. The book, which focuses on a dental visit, was evaluated in a separate study by a pediatric dentist with 10 years of clinical experience for age appropriateness and its alignment with behavior guidance principles. It was selected from among 24 books and considered suitable for this purpose. A clinical examination will be performed, and the dmft/dmfs scores, Modified Gingival Index, and Plaque Index will be recorded.

Behavioral: Standard Dental Storybook; Behavioral: Standard Behavior Guidance

AI-generated personalized storybook

EXPERIMENTAL

The Venham Picture Test (VPT; child-reported) and Facial Image Scale (FIS; child- and clinician-reported) will be administered. Heart rate and oxygen saturation will be measured using a pulse oximeter and recorded as baseline physiological parameters. The personalized storybook prepared for the child will be read together with the clinician on a tablet. A clinical examination will be performed, and the dmft/dmfs scores, Modified Gingival Index, and Plaque Index will be recorded.

Behavioral: AI-Generated Personalized Dental Storybook; Behavioral: Standard Behavior Guidance

Interventions

AI-Generated Personalized Dental Storybook BEHAVIORAL

Before the dental procedure begins, the dentist will read an artificial intelligence-generated personalized dental storybook to the participant. The storybook will be individually developed based on the participant's age, interests, preferences, and personal characteristics to familiarize the participant with the dental environment and procedures as a behavior guidance intervention.

AI-generated personalized storybook

Standard Dental Storybook BEHAVIORAL

Before the dental procedure begins, the dentist will read a standardized dental storybook to the participant. The storybook will provide general information about the dental environment and dental procedures without personalized content and will be used as a behavior guidance intervention.

Standard dental storybook

Standard Behavior Guidance BEHAVIORAL

Participants will receive routine non-pharmacological behavior guidance before and during the dental procedure according to standard pediatric dental practice. Standard behavior guidance techniques, including tell-show-do, positive reinforcement, distraction and age-appropriate communication strategies will be used as clinically indicated.

AI-generated personalized storybook; Control Group; Standard dental storybook

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants classified as Frankl II (Negative) or Frankl III (Positive) according to the Frankl Behavior Rating Scale.
• Systemically healthy participants classified as American Society of Anesthesiologists (ASA) Physical Status I.
• Participants with at least two primary molars requiring Class I occlusal restorations for superficial carious lesions that do not require local anesthesia.
• Parents or legal guardians who voluntarily provide written informed consent for participation in the study.

You may not qualify if:

• Participants younger than 4 years or older than 7 years of age.
• Participants with systemic diseases or developmental delay.
• Participants with a current psychiatric disorder or who have been under psychiatric follow-up within the previous 6 months.
• Participants receiving psychotropic medication.
• Participants diagnosed with neurodevelopmental disorders (e.g., autism spectrum disorder or moderate-to-severe attention-deficit/hyperactivity disorder).
• Participants with communication or developmental impairments that may interfere with the reliable administration of the study assessment scales.
• Children with special health care needs.
• Participants with general or dental developmental anomalies (e.g., amelogenesis imperfecta, cleft lip and/or palate, osteogenesis imperfecta).
• Participants classified as Frankl I (Definitely Negative) or Frankl IV (Definitely Positive) according to the Frankl Behavior Rating Scale.
• Participants with a history of spontaneous dental pain or symptomatic teeth requiring emergency treatment.
• Participants whose parent or legal guardian does not provide written informed consent.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

epartment of Pediatric Dentistry, Eskişehir Osmangazi University Faculty of Dentistry

Eskişehir, Turkey (Türkiye)

RECRUITING

Study Officials

• İrem Bağ Baytar

  Eskişehir Osmangazi University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Associate Professor

CONTACT

+905064379883; irem.bag@ogu.edu.tr

Research Assistant

CONTACT

+905062177860; tubanurarol@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 21, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): November 12, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)