An interventional study of AI-Generated Personalized Dental Storybook and Standard Dental Storybook in Dental Anxiety in Children, Behavior Management and Pediatric Dental Anxiety, sponsored by Eskisehir Osmangazi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Prevention
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.
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:
The clinical protocol comprises three sequential visits scheduled at two-week intervals:
Outcome Assessments: Dental anxiety and cooperative behavior will be evaluated across all sessions at predetermined pre- and post-intervention intervals using:
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 69 is below the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →Eskisehir Osmangazi University is the lead sponsor of 153 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
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.
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 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.
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 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.
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 minutes
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 minutes
Oxygen Saturation
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 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.
Time frame: At the end of each session: Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4)
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)
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)
Plan to share: No — We plan to note that when research results are published as scientific outputs/manuscript, interested readers can access them through the corresponding author.
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