Behavior Management, Dental Anxiety in Children, Pediatric Dental Anxiety
Conditions
Keywords
pediatric dentistry, dental anxiety, behavior management, artificial intelligence, personalized storytelling, 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.
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: 1. 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. 2. 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. 3. 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.
Interventions
BEHAVIORALAI-Generated Personalized Dental Storybook
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.
BEHAVIORALStandard Dental Storybook
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.
BEHAVIORALStandard Behavior Guidance
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.
Sponsors
Eskisehir Osmangazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Image Scale (FIS) score - child reported | 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 | 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. |
| Facial Image Scale (FIS) score - clinician reported | 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 | 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. |
| Venham Picture Test (VPT) score | 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 | 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. |
| Pulse | 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 | This measurement will be performed to provide an objective assessment of the child's physiological response to dental treatment-related anxiety. |
| Oxygen Saturation | 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 | This measurement will be performed to provide an objective assessment of the child's physiological response to dental treatment-related anxiety. |
| Venham Clinical Cooperation Scale (VCCS) score | At the end of each session: Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index (Silness and Löe) | Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4) | The Silness and Löe Plaque Index assesses the presence and thickness of dental plaque in relation to the gingival margin. The individual Plaque Index score is calculated by summing the scores obtained for the examined teeth and dividing the total by the number of teeth examined. Score 0: No plaque is present. Score 1: A thin film of plaque is present at the gingival margin. The plaque cannot be observed visually and can only be detected by probing with a periodontal probe. Score 2: A moderate accumulation of plaque is visible at the gingival margin. No plaque is present in the proximal areas. The plaque is readily detectable by visual examination. Score 3: A substantial accumulation of plaque is present at the gingival margin, with the interdental areas filled with plaque. |
| Modified Gingival Index | Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4) | The Modified Gingival Index (MGI) is a non-invasive clinical index used to assess gingival inflammation based on visual assessment of gingival color, swelling, and other clinical signs of inflammation. Gingival tissues are scored on a scale from 0 to 4, with higher scores indicating greater severity of gingival inflammation. Unlike conventional gingival indices, the MGI does not require probing or assessment of bleeding on probing. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAssociate Professor
CONTACTResearch Assistant
PRINCIPAL_INVESTIGATORİrem Bağ Baytar
Eskişehir Osmangazi University Faculty of Dentistry
Outcome results
None listed