Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence

NCT06276478 | Completed

• 1 other identifier: 2024-PEDOAI
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Dental Phobia

Outcome Measures

Primary Outcomes (1)

• Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995)

  Baseline (T0) and after 14 days (T1)

Secondary Outcomes (4)

• Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997)

  Baseline (T0) and after 14 days (T1)

• Change in Bleeding on Probing - BoP (Löe H. et al.,1967)

  Baseline (T0) and after 14 days (T1)

• Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964)

  Baseline (T0) and after 14 days (T1)

• International Caries Detection and Assessment System - ICDAS

  Baseline

Study Arms (2)

Trial group

EXPERIMENTAL

Other: AI-video

Control group

ACTIVE COMPARATOR

Other: Verbal instructions

Interventions

AI-video OTHER

Video administration for the explanation of the dental procedures followed by verbal instructions.

Trial group

Verbal instructions OTHER

Only verbal instructions will be administered for the explanation of the dental procedures

Control group

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age between 5 and 10 years
• Modified Dental Anxiety Scale (MDAS) (Humphris GM et al. 1995) greater than or equal to children must score equal to or higher than 19 in the questionnaire based on the "The modified dental anxiety scale."
• FLACC score (Merkel, S. I. et al., 1997) greater than or equal to 4
• Simplified Oral Hygiene Index (OHI-S) (Greene JC et al, 1964) greater than or equal to 1.3.

You may not qualify if:

• Previous Traumatic Dental/Orthodontic Treatments
• Previous Hospitalizations
• Intellectual Disabilities and Psychiatric Disorders

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, MSc, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: March 4, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 5, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)