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Dental AnxietyNCT06276478

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

A study testing AI-video and Verbal instructions in people with Dental Anxiety and Dental Phobia, run by University of Pavia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Dental Anxiety, Dental Phobia
What is being tested?
AI-video and Verbal instructions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteItaly
Study dates
4 Mar 2024to 5 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

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 5 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

    Pavia, Lombardy, 27100

Other trials in Italy

About this study

Official title: Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence: Randomized Clinical Trial

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.

Read more

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.

Read the detailed description

The World Health Organization classifies dental phobia as a disease, making it a significant concern in the field of dentistry and a considerable challenge for practitioners. It has been included in the International Classification of Diseases (ICD-10) as one of the specific phobias. According to WHO estimates, it affects 15-20% of the population. Notably, it is estimated that over 50% of pediatric patients may exhibit varying degrees of anxiety during dental treatments. Therefore, it is desirable to develop methods to address this issue.

Existing literature already contains studies using anxiety control methods for pediatric patients. For example, in the review by S. L. Ainscough and colleagues, a study of 30 subjects aged 4 to 8 was cited, in which it was demonstrated that music can be an effective strategy to alleviate anxiety during dental sessions. In a previous study 13 subjects aged 11 to 16 were interviewed, showing how careful and optimal dentist-patient communication positively influences the approach to dental care. An illustrative study considered 150 randomly selected children aged 4 to 8, divided into five groups of 30 patients each. Anxiety was assessed using scales such as the Facial Image Scale and the Venham's Anxiety Scale, alongside physiological parameters like the physiological pulse rate. The study aimed to prove the effectiveness of modified tell-show-do techniques, such as tell-play-do, tell-play-do with a dentist smartphone game, tell-show-play-do, and ask-tell-ask.

Therefore, the objective of this study is to use Artificial Intelligence (AI) to provide a technique to positively decondition psychologically pediatric patients from the fear of dentists and make them more engaged and receptive to dental sessions with an animated cartoon created with AI with a dialogue tailored to pediatric patients with dental anxiety.

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.

Being tested
AI-video, Verbal instructions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-videoOther

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

  • Verbal instructionsOther

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

Study groups in NCT06276478
Study groupRoleWhat they receive
Trial groupExperimentalNot described
Receives: Other: AI-video
Control groupActive comparatorNot described
Receives: Other: Verbal instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline (T0) and after 14 days (T1)

Secondary outcomes (4)
  1. Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997)

    Measured: Baseline (T0) and after 14 days (T1)

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

    Measured: Baseline (T0) and after 14 days (T1)

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

    Measured: Baseline (T0) and after 14 days (T1)

  4. International Caries Detection and Assessment System - ICDAS

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start4 Mar 2024
  3. Primary completion1 Jul 2024
  4. Study completion5 Jul 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06276478
Sponsor's protocol ID
2024-PEDOAI
Status last verified
Oct 2024
First submitted
16 Feb 2024
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available upon motivated request to the Principal Investigator.

Questions about this trial

What is this clinical trial studying?

A study testing AI-video and Verbal instructions in people with Dental Anxiety and Dental Phobia, run by University of Pavia at 1 site in Italy.

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 3 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: finished, as of the sponsor's last update on 29 Oct 2024. 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 Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995) (time frame: Baseline (T0) and after 14 days (T1)). 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 29 Oct 2024.

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