AI-Generated Personalized Story Book to Improve Patient Behaviour

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.

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.