AI-Generated Personalized Story Book to Improve Patient Behaviour | NCT07778134 | Trialant

RecruitingInterventionalNot ApplicableUpdated Aug 21, 2026

AI-Generated Personalized Story Book to Improve Patient Behaviour

The Effectiveness of an Artificial Intelligence-Generated, Patient-Specific Storybook for Behaviour Guidance: A Randomized Controlled Trial

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07778134
Lead Sponsor: Eskisehir Osmangazi UniversityOTHER
Overall Status: Recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 69Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Jun 8, 2026Actual
Primary Completion Date: Nov 12, 2027Estimated
Completion Date: Nov 12, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: The Effectiveness of an Artificial Intelligence-Generated, Patient-Specific Storybook for Behaviour Guidance: A Randomized Controlled Trial
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

The medical conditions and diseases this study investigates.

Dental Anxiety in Children
Behavior Management
Pediatric Dental Anxiety

Interventions

The treatments and procedures being evaluated in this study.

AI-Generated Personalized Dental Storybook
Standard Dental Storybook
Standard Behavior Guidance

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Associate ProfessorContact

irem.bag@ogu.edu.tr+905064379883

Locations

Where the study is run and whether each site is currently recruiting.

epartment of Pediatric Dentistry, Eskişehir Osmangazi University Faculty of DentistryRecruiting

Eskişehir, Turkey (Türkiye)

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Eskisehir Osmangazi UniversityOTHER

Similar Studies

Other registered studies that closely resemble this one.

Detailed Description

This randomized controlled clinical trial aims to evaluate the effectiveness of artificial intelligence (AI)-generated, patient-specific digital storybooks in reducing dental anxiety and enhancing clinical cooperation among pediatric dental patients undergoing preventive and restorative treatments.

Eligible children whose parents or legal guardians provide written informed consent (and who provide child assent according to age and developmental maturity) will be randomly allocated into three parallel study arms:

Experimental Group (AI-Driven Personalized Storybook): Patients in this group will receive a personalized digital storybook intervention before dental procedures. The narrative is dynamically constructed using a large language model (Google Gemini API) based on demographic, behavioral, sensory, and interest profile data collected from both the parent and child via a dedicated interface. The AI-generated content is developed under structured prompt engineering protocols to ensure age-appropriate language, positive psychological framing, and alignment with Tell-Show-Do (TSD) principles. Crucially, all AI-generated materials undergo clinical screening and approval by the investigator before presentation on a digital tablet.
Active Control Group (Standard Published Storybook): Patients will be presented with pre-selected, professionally validated, non-personalized standard children's dental storybooks via a tablet prior to the procedures.
Control Group (Conventional Behavior Guidance): Patients will receive standard basic behavior guidance techniques, primarily verbal communication and traditional Tell-Show-Do, without storybook intervention.

The clinical protocol comprises three sequential visits scheduled at two-week intervals:

Session 1: Baseline assessments, oral examination (dmft/dmfs, modified gingival index, plaque index), oral hygiene motivation, and preventive interventions (oral prophylaxis, topical fluoride, and/or pit and fissure sealants).
Session 2: Class I restorative treatment of a cavitated primary/permanent molar using high-viscosity glass ionomer cement (HVGIC) following cavity preparation.
Session 3: Restorative treatment of another cavitated tooth under standard Tell-Show-Do protocol without storybook reading, along with gingival and plaque index re-evaluations.

Outcome Assessments: Dental anxiety and cooperative behavior will be evaluated across all sessions at predetermined pre- and post-intervention intervals using:

Subjective/Self-Report Measures: Venham Picture Test (VPT) and child-rated Facial Image Scale (FIS).
Operator-Reported Measures: Dentist-rated Facial Image Scale (FIS) and the Venham Clinical Cooperation Scale (VCCS).
Physiological Biomarkers: Real-time pulse rate and oxygen saturation (SpO2) monitoring via pulse oximetry.
Clinical Performance: Completion status and permission levels of targeted preventive and restorative procedural steps.

Stringent exclusion and drop-out criteria are established, including requirements for local anesthesia, pulp therapy, or emergency management during the trial sessions, ensuring standardized procedural complexity and patient safety.