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.
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
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.
- Conditions
- Dental Anxiety, Dental Phobia
- 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 group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Not described Receives: Other: AI-video |
| Control group | Active comparator | Not described Receives: Other: Verbal instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995)
Measured: 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)
Measured: Baseline (T0) and after 14 days (T1)
Change in Bleeding on Probing - BoP (Löe H. et al.,1967)
Measured: Baseline (T0) and after 14 days (T1)
Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964)
Measured: Baseline (T0) and after 14 days (T1)
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.
- First posted26 Feb 2024
- Study start4 Mar 2024
- Primary completion1 Jul 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, MSc, PhD, Principal investigator, Study Principal Investigator
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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychological Deconditioning of Pediatric Patients With Dental Anxiety Through Artificial Intelligence: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06276478
- Acronym / sponsor ID
- 2024-PEDOAI
- Conditions
- Dental Anxiety, Dental Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 26 Feb 2024 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Other: AI-video |
| Control group | Active comparator | Other: Verbal instructions |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous Traumatic Dental/Orthodontic Treatments
- Previous Hospitalizations
- Intellectual Disabilities and Psychiatric Disorders
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-videoVideo administration for the explanation of the dental procedures followed by verbal instructions. | Other | Trial group |
| Verbal instructionsOnly verbal instructions will be administered for the explanation of the dental procedures | Other | Control group |
Primary outcome
Change in Modified Dental Anxiety Scale - MDAS (Humphris GM et al. 1995)
Time frame: Baseline (T0) and after 14 days (T1)
4 secondary outcomes
Change in Face, Leg, Activity, Cry, Consolability Scale - FLACC (Merkel, S. I. et al., 1997)
Time frame: Baseline (T0) and after 14 days (T1)
Change in Bleeding on Probing - BoP (Löe H. et al.,1967)
Time frame: Baseline (T0) and after 14 days (T1)
Change in Simplified Oral Hygiene Index - OHI-S (Greene JC et al, 1964)
Time frame: Baseline (T0) and after 14 days (T1)
International Caries Detection and Assessment System - ICDAS
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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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. This study is not recruiting at the moment.
Andrea Scribante, DDS, MSc, PhD principal investigator
Study Principal Investigator
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-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.