Clinical trial NCT05553262: A Protocol to Streamline Dental Care in Autistic Children
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Dentistry
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: ULSS 6 Euganea
name: Nastrificio Victor S.p.A.
First posted: 2022-09-23
Enrollment: 170
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Collaboration
timeFrame: 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 outcomes:
measure: Acceptance
timeFrame: Year 1, month 2
measure: Acceptance
timeFrame: Year 1, month 4
measure: Acceptance
timeFrame: Year 1, month 6
measure: Acceptance
timeFrame: Year 1, month 8
measure: Acceptance
timeFrame: Year 1, month 10
measure: Acceptance
timeFrame: Year 1, month 12
measure: Acceptance
timeFrame: Year 2, month 2
measure: Acceptance
timeFrame: Year 2, month 4
measure: Acceptance
timeFrame: Year 2, month 6
measure: Acceptance
timeFrame: Year 2, month 8
measure: Acceptance
timeFrame: Year 2, month 10
measure: Acceptance
timeFrame: Year 2, month 12
measure: Acceptance
timeFrame: Year 3, month 2
measure: Acceptance
timeFrame: Year 3, month 4
measure: Acceptance
timeFrame: Year 3, month 6
measure: Acceptance
timeFrame: Year 3, month 8
measure: Acceptance
timeFrame: Year 3, month 10
measure: Acceptance
timeFrame: Year 3, month 12
Other outcomes:
Locations:
city: Piove Di Sacco
country: Italy
facility: Piove di Sacco Hospital
state: PD
Study officials:
affiliation: University of Padova
name: Carla Mucignat, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: AlBhaisi IN, Kumar MSTS, Engapuram A, Shafiei Z, Zakaria ASI, Mohd-Said S, McGrath C. Effectiveness of psychological techniques in dental management for children with autism spectrum disorder: a systematic literature review. BMC Oral Health. 2022 May 6;22(1):162. doi: 10.1186/s12903-022-02200-7.
citation: Aljubour A, AbdElBaki M, El Meligy O, Al Jabri B, Sabbagh H. Effect of Culturally Adapted Dental Visual Aids on Oral Hygiene Status during Dental Visits in Children with Autism Spectrum Disorder: A Randomized Clinical Trial. Children (Basel). 2022 May 5;9(5):666. doi: 10.3390/children9050666.
citation: Alvares GA, Mekertichian K, Rose F, Vidler S, Whitehouse AJO. Dental care experiences and clinical phenotypes in children on the autism spectrum. Spec Care Dentist. 2023 Jan;43(1):17-28. doi: 10.1111/scd.12746. Epub 2022 Jun 2.
citation: Shalabi MASA, Khattab NMA, Elheeny AAH. Picture Examination Communication System Versus Video Modelling in Improving Oral Hygiene of Children with Autism Spectrum Disorder: A Prospective Randomized Clinical Trial. Pediatr Dent. 2022 Jan 15;44(1):25-31.
citation: Yost Q, Nelson T, Sheller B, McKinney CM, Tressel W, Chim AN. Children with Autism Spectrum Disorder Are Able to Maintain Dental Skills: A Two-Year Case Review of Desensitization Treatment. Pediatr Dent. 2019 Sep 15;41(5):397-403.