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

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)

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Behavioral support

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 Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PD
    • Piove Di Sacco, PD, Italy, 35028
      • Piove di Sacco Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral support; 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; Behavioral support as described under 'Arm description'.
No Intervention: Control No behavioral support; 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?

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

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: ULSS 6 Euganea; Nastrificio Victor S.p.A.
• Investigators: Principal Investigator: Carla Mucignat, Ph.D., University of Padova

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Autism; Dentistry
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: AUTISM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only anonymized data, including age, sex, diagnosis and the collected measurements, will be made available to other researchers. Individual Participant data that allow identification of the single participant cannot be shared, as requested by the Ethical Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No