A Protocol to Streamline Dental Care in Autistic Children

Study Overview
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Brief Summary
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The investigators aim at creating a dedicated pathway to allow accessibility to dental care for ASD children within a hospital Dentistry Department, in order to diminish the need for general anesthesia. Visual pedagogy, parent training, a strict schedule for appointments (every two months) spanning over three years and longer duration of dedicated examination are set up for a group of ASD children, whose behavior is compared to that of children seen one or twice a year.

Detailed Description
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Treated group: Enrollment: caregivers receive instructions and a visual pedagogy aid with instructions for toothbrushing. They complete also enrollment and informed consent forms. At the first visit: caregivers receive a dental mirror to be used at home. Children are free to explore the office and dental room. Subsequent visits, every two months for three years: trials are made to establish contact with children, make them seat at the dentist's chair, execute dental visits and treatments as needed. Control group: subjects (similar inclusion and exclusion criteria) that access the Department for clinical reasons or control visits, but cannot comply with the strict two-months schedule.

Official Title
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A Three-years Project for Assistance and Dental Care of Children With Autistic Spectrum Disorder at the Community Dentistry Unit - Piove di Sacco Hospital (Padua, Italy)

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Behavioral support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 4 to 13 years old at the beginning of the treatment, Diagnosis: formally diagnosed by a Neuro-psychiatrist and recognized by authorities (for school support) as having Autistic Spectrum Disorder (ASD), possibly also in the frame of genetic syndromes, or Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS), a diagnosis present in DSM 4 and merged to ASD in DSM 5. Exclusion Criteria: Age outside the selected range additional diseases, preventing autonomous oral hygiene (e.g., motor diseases), for the Treated Group: familiarity with dental treatments (possible one or few visits in the past, but not on a regular base)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Both treated and control groups will receive the same clinical intervention (dental care) when needed. Treated group will have visits every two months, visual pedagogy and caregiver instructions for oral hygiene maintenance at home. Control group will receive dentist visits twice a year (or more often if clinically required) according to Italian Ministry of Health guidelines for pediatric dentistry.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral support<br>Usual clinical intervention and in addition: visual pedagogy, instruction of caregivers, a visit every two months for three years, fixed duration of the visit (one hour) regardless of patients' collaboration. General anesthesia if needed. | Behavioral: Behavioral support<br>* Behavioral support as described under 'Arm description'.<br>|
| No Intervention: Control No behavioral support<br>Usual clinical treatment (dentist visit and treatments). No visual pedagogy and instruction of caregivers. Twice a year schedule (more if needed), duration of the visits according to compliance. General anesthesia if needed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collaboration | Degree of collaboration on Frankl's scale, from 0 (none) to 3 (optimal) | Change in degree of collaboration from baseline at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 1, month 2 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 1, month 4 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 1, month 6 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 1, month 8 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 1, month 10 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 1, month 12 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 2, month 2 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 2, month 4 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 2, month 6 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 2, month 8 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 2, month 10 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 2, month 12 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 3, month 2 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 3, month 4 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 3, month 6 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 3, month 8 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 3, month 10 | 
| Acceptance | Acceptance of every action or instrument: Yes/No | Year 3, month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Dentistry