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Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder

RecruitingNAAges 6 Years - 14 YearsAllUniversity of Milan
NCT07906288 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interaction, as well as repetitive and stereotyped behaviors. Home oral hygiene procedures are often resisted by children with ASD; consequently, maintaining an adequate level of oral hygiene can be challenging, leading to an increased risk of dental caries and gingivitis compared with children without ASD. Children with ASD frequently experience difficulties attending dental appointments, as the dental setting falls outside their usual routine. Furthermore, the smells, sounds, and visual stimuli present in the dental environment may be overwhelming for a child with ASD, causing anxiety that can exacerbate stereotyped behaviors and self-injurious actions, thereby making completion of the dental examination difficult. Given the sensory processing

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female children aged 6-14 years; * Diagnosis of Autism Spectrum Disorder (ASD) Level II-III; * Baseline cooperation at T0 classified as Frankl Behavior Rating Scale score 1-2 (uncooperative child); * Failure to complete at least two steps of the dental examination protocol; * Absence of coulrophobia (fear of clowns); * Absence of dental emergencies requiring immediate treatment; * Availability of a parent or caregiver to accompany the child to the familiarization sessions; * Written informed consent signed by the parent or caregiver for participation in the study. Exclusion Criteria: * Diagnosis of Autism Spectrum Disorder (ASD) Level I; * Baseline cooperation at T0 classified as Frankl Behavior Rating Scale score 3-4 (cooperative child); * Completion of more than two steps of the dental examination protocol; * Presence of coulrophobia (fear of clowns); * Presence of dental emergencies requiring immediate treatment; * Unavailability of a parent or caregiver to accompany the child to the familiarization sessions; * Lack of written informed consent signed by the parent or caregiver for participation in the study.
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What it tests

  • Familiarization sessions using clown therapy
  • Familiarization sessions with conventional methods
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Where

1 site
Dental Clinic G.Vogel, saint paul and charles hospital
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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