Dental Anxiety in ChildrenAI-STORYNCT07778134
AI-Generated Personalized Story Book to Improve Patient Behaviour
A study testing AI-Generated Personalized Dental Storybook, Standard Dental Storybook and Standard Behavior Guidance in people with Dental Anxiety in Children and Behavior Management, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety in Children, Behavior Management, Pediatric Dental Anxiety
- What is being tested?
- AI-Generated Personalized Dental Storybook, Standard Dental Storybook and Standard Behavior Guidance
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2026to 12 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
epartment of Pediatric Dentistry, Eskişehir Osmangazi University Faculty of Dentistry
Eskişehir
Associate Professor, +905064379883, irem.bag@ogu.edu.tr
Research Assistant, +905062177860, tubanurarol@gmail.com
About this study
Official title: The Effectiveness of an Artificial Intelligence-Generated, Patient-Specific Storybook for Behaviour Guidance: A Randomized Controlled 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.
Read the 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.
- Being tested
- AI-Generated Personalized Dental Storybook, Standard Dental Storybook, Standard Behavior Guidance
- Keywords
- pediatric dentistry, dental anxiety, behavior management, artificial intelligence, personalized storytelling, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Personalized Dental StorybookBehavioural
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.
Standard Dental StorybookBehavioural
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.
Standard Behavior GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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). Receives: Behavioral: Standard Behavior Guidance |
| Standard dental storybook | Active comparator | 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. Receives: Behavioral: Standard Dental Storybook; Behavioral: Standard Behavior Guidance |
| AI-generated personalized storybook | Experimental | 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. Receives: Behavioral: AI-Generated Personalized Dental Storybook; Behavioral: Standard Behavior Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of each session: Session 1 (Day 0), Session 2 (Week 2), and Session 3 (Week 4)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start8 Jun 2026
- Primary completion12 Nov 2027 (estimated)
- Study completion12 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anxiety in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Bag, Eskisehir Osmangazi University
- Investigators
- İrem Bağ Baytar, Principal investigator, Eskişehir Osmangazi University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778134
- Sponsor's protocol ID
- TDH-2026-4010
- Other IDs
- TDH-2026-4010
- Acronym
- AI-STORY
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to note that when research results are published as scientific outputs/manuscript, interested readers can access them through the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Artificial Intelligence-Generated, Patient-Specific Storybook for Behaviour Guidance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07778134
- Acronym / sponsor ID
- AI-STORY / TDH-2026-4010
- Keywords
- pediatric dentistry, dental anxiety, behavior management, artificial intelligence, personalized storytelling, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 12 Nov 2027 (estimated)
- Study completion
- 12 Nov 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard Behavior GuidanceThe 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). |
| Standard dental storybook | Active comparator | Behavioral: Standard Dental Storybook, Behavioral: Standard Behavior GuidanceThe 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. |
| AI-generated personalized storybook | Experimental | Behavioral: AI-Generated Personalized Dental Storybook, Behavioral: Standard Behavior GuidanceThe 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Generated Personalized Dental StorybookBefore 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. | Behavioural | AI-generated personalized storybook |
| Standard Dental StorybookBefore 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. | Behavioural | Standard dental storybook |
| Standard Behavior GuidanceParticipants 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. | Behavioural | AI-generated personalized storybook, Control Group, Standard dental storybook |
Primary outcome
Facial Image Scale (FIS) score - child reported
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
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
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
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
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
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
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
This measurement will be performed to provide an objective assessment of the child's physiological response to dental treatment-related anxiety.
Oxygen Saturation
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
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
Time frame: 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.
2 secondary outcomes
Plaque Index (Silness and Löe)
Time frame: Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)
Modified Gingival Index
Time frame: Baseline (Session 1, Day 0) and at the follow-up visit (Session 3, Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
İrem Bağ Baytar principal investigator
Eskişehir Osmangazi University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Generated Personalized Dental Storybook, Standard Dental Storybook and Standard Behavior Guidance in people with Dental Anxiety in Children and Behavior Management, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Associate Professor (+905064379883, irem.bag@ogu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Image Scale (FIS) score - child reported (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.