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Completed

NCT Number: NCT05553262

A Protocol to Streamline Dental Care in Autistic Children

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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Piove di Sacco Hospital

Piove di Sacco, PD, 35028, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Behavioral support

Behavioral

Behavioral support as described under 'Arm description'.

Primary outcomes

  1. Collaboration

    Time frame: 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 outcomes

  1. Acceptance

    Time frame: Year 1, month 2

    Acceptance of every action or instrument: Yes/No

  2. Acceptance

    Time frame: Year 1, month 4

    Acceptance of every action or instrument: Yes/No

  3. Acceptance

    Time frame: Year 1, month 6

    Acceptance of every action or instrument: Yes/No

  4. Acceptance

    Time frame: Year 1, month 8

    Acceptance of every action or instrument: Yes/No

  5. Acceptance

    Time frame: Year 1, month 10

    Acceptance of every action or instrument: Yes/No

  6. Acceptance

    Time frame: Year 1, month 12

    Acceptance of every action or instrument: Yes/No

  7. Acceptance

    Time frame: Year 2, month 2

    Acceptance of every action or instrument: Yes/No

  8. Acceptance

    Time frame: Year 2, month 4

    Acceptance of every action or instrument: Yes/No

  9. Acceptance

    Time frame: Year 2, month 6

    Acceptance of every action or instrument: Yes/No

  10. Acceptance

    Time frame: Year 2, month 8

    Acceptance of every action or instrument: Yes/No

  11. Acceptance

    Time frame: Year 2, month 10

    Acceptance of every action or instrument: Yes/No

  12. Acceptance

    Time frame: Year 2, month 12

    Acceptance of every action or instrument: Yes/No

  13. Acceptance

    Time frame: Year 3, month 2

    Acceptance of every action or instrument: Yes/No

  14. Acceptance

    Time frame: Year 3, month 4

    Acceptance of every action or instrument: Yes/No

  15. Acceptance

    Time frame: Year 3, month 6

    Acceptance of every action or instrument: Yes/No

  16. Acceptance

    Time frame: Year 3, month 8

    Acceptance of every action or instrument: Yes/No

  17. Acceptance

    Time frame: Year 3, month 10

    Acceptance of every action or instrument: Yes/No

  18. Acceptance

    Time frame: Year 3, month 12

    Acceptance of every action or instrument: Yes/No

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Azienda Ulss 6 Euganea
  • Nastrificio Victor S.p.A.

Registry information

Official study 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)

Acronym: DentAutism

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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