protocolSection identificationModule nctId: NCT06276478, orgStudyIdInfo id: 2024-PEDOAI, briefTitle: Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: Pediatric patients who will be attending dental treatment at both the Orthodontics and Pediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences at the University of Pavia, Pavia, Italy and a private dental practice in Genoa, Italy, will be recruited for the study.A cartoon version of a small molar will be drawn using the software Paint (version 22000.0, Microsoft Corporation, Redmond, Washington State, U.S.). The drawing will be animated using an AI-based software (Sketch MetaDemolab, Meta AI Research, Astor Place, New York city, New York, U.S.). A text will be created in collaboration with OpenAI (version 3.5, Open AI, San Francisco, California, U.S.) to be integrated into the video, utilizing terminology deemed most suitable for a patient with dental anxiety. The text will be transformed from written to spoken dialogue using an AI-based software (Flexclip, version 5.6.0, PearlMountain, Hong Kong, China), and then incorporated into the video.Children will undergo the first dental visit at the baseline (T0), in which the following indexes will be assessed: Modified Dental Anxiety Scale (MDAS), Face-Leg-Activity-Cry-Consolability Scale (FLACC), Simplified Oral Hygiene Index (OHI-S), Bleeding on Probing (BOP) and the International Caries Detection and Assessment System (ICDAS). They will be randomly divided into two group:* in the Trial group, patients will watch the the video, and then the tell-show-do technique will be used to explain the dental procedures;* in the Control group, only the "tell-show-do" technique will be used. Variables considered will include age, gender, and the presence/absence of a parent or another companion.At the second visit (T1), scheduled approximately after two weeks, the variables will be re-evaluated and professional debridement will be performed with a piezoelectric instrument (Satelect Acteon Newton p5 xs,Acteon Group, Mèrignac, France and Sonicflex Kavo, KaVo Dental, Biberach an der Riss, Germany) and manual scaler/curettes (Courette 9/10, 11/12 and 13/14 Gracey and Scaler lm 23, Hu Friedy, Europe). Values will be registered again, for the third time, after the professional debridement., conditionsModule conditions: Dental Anxiety, conditions: Dental Phobia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: AI-video, interventions name: Verbal instructions, outcomesModule primaryOutcomes measure: Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995), secondaryOutcomes measure: Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997), secondaryOutcomes measure: Change in Bleeding on Probing - BoP (Löe H. et al.,1967), secondaryOutcomes measure: Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964), secondaryOutcomes measure: International Caries Detection and Assessment System - ICDAS, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False