A Protocol to Streamline Dental Care in Autistic Children (DentAutism)

University of Padova

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Behavioral support

Study type: Interventional

Funder types: Other

Identifiers

NCT05553262

AUTISM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 4 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Behavioral support

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral support

Control No behavioral support

No Intervention group

Description:

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.