A Protocol to Streamline Dental Care in Autistic Children

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT05553262
• Lead Sponsor: University of Padova

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Collaboration	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.	Degree of collaboration on Frankl's scale, from 0 (none) to 3 (optimal)

Secondary Outcome Measures

Name	Time	Method
Acceptance	Year 3, month 12	Acceptance of every action or instrument: Yes/No

Trial Locations

Locations (1)

Piove di Sacco Hospital; 🇮🇹 Piove Di Sacco, PD, Italy