A Protocol to Streamline Dental Care in Autistic Children

Autism Spectrum Disorder Clinical Trial

— DentAutism  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553262
• Other study ID #: AUTISM
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2022
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Behavioral support
Behavioral support as described under 'Arm description'.

Locations

Country	Name	City	State
Italy	Piove di Sacco Hospital	Piove Di Sacco	PD

Sponsors (3)

Lead Sponsor	Collaborator
University of Padova	Nastrificio Victor S.p.A., ULSS 6 Euganea

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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). pii: 666. doi: 10.3390/children9050666. — View 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. 2022 Jun 2. doi: 10.1111/scd.12746. [Epub ahead of print] — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptance	Acceptance of every action or instrument: Yes/No	Year 1, month 2
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 1, month 4
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 1, month 6
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 1, month 8
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 1, month 10
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 1, month 12
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 2, month 2
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 2, month 4
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 2, month 6
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 2, month 8
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 2, month 10
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 2, month 12
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 3, month 2
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 3, month 4
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 3, month 6
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 3, month 8
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 3, month 10
Secondary	Acceptance	Acceptance of every action or instrument: Yes/No	Year 3, month 12