AI-Generated Personalized Story Book to Improve Patient Behaviour
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorEskisehir Osmangazi University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Generated Personalized Dental Storybook
BehavioralBefore 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.
Standard Dental Storybook
BehavioralBefore 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 Behavior Guidance
BehavioralParticipants 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.
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Standard dental storybookActive comparator 2 interventions
Group C: AI-generated personalized storybookExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
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 minutes2
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.
Time frame
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 minutes3
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.
Time frame
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 minutes4
Pulse
This measurement will be performed to provide an objective assessment of the child's physiological response to dental treatment-related anxiety.
Time frame
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 minutesSecondary outcomes
1
Plaque Index (Silness and Löe)
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.
Time frame
Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)2
Modified Gingival Index
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.
Time frame
Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)Sponsors and contacts
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Source ClinicalTrials.gov