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Autism Spectrum DisorderDentAutismNCT05553262

A Protocol to Streamline Dental Care in Autistic Children

A study testing Behavioral support in people with Autism Spectrum Disorder, run by University of Padova at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 13 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Behavioral support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteItaly
Study dates
1 Jan 2019to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Piove di Sacco Hospital

    Piove di Sacco, PD, 35028

Other trials in Italy

About this study

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)

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.

Read the 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.

Being tested
Behavioral support
Keywords
Autism, Dentistry
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral supportBehavioural

    Behavioral support as described under 'Arm description'.

Study groups in NCT05553262
Study groupRoleWhat they receive
Behavioral supportExperimentalUsual 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.
Receives: Behavioral: Behavioral support
Control No behavioral supportNo interventionUsual 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Collaboration

    Degree of collaboration on Frankl's scale, from 0 (none) to 3 (optimal)

    Measured: 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 (18)

  1. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 1, month 2

  2. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 1, month 4

  3. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 1, month 6

  4. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 1, month 8

  5. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 1, month 10

  6. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 1, month 12

  7. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 2, month 2

  8. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 2, month 4

  9. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 2, month 6

  10. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 2, month 8

  11. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 2, month 10

  12. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 2, month 12

  13. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 3, month 2

  14. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 3, month 4

  15. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 3, month 6

  16. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 3, month 8

  17. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 3, month 10

  18. Acceptance

    Acceptance of every action or instrument: Yes/No

    Measured: Year 3, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05553262
Sponsor's protocol ID
AUTISM
Acronym
DentAutism
Status last verified
Sep 2022
First submitted
14 Sep 2022
Last updated
27 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 35524299

  • 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.

    PubMed 35626843

  • 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.

    PubMed 35654391

  • 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.

    PubMed 35232533

  • 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.

    PubMed 31648672

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral support in people with Autism Spectrum Disorder, run by University of Padova at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05553262, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.

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