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| Name | Class |
|---|---|
| Azienda Ulss 6 Euganea | OTHER |
| Nastrificio Victor S.p.A. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral support | Experimental | 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. |
|
| Control No behavioral support | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral support | Behavioral | Behavioral support as described under 'Arm description'. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Mucignat, Ph.D. | University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piove di Sacco Hospital | Piove di Sacco | PD | 35028 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35524299 | Background | 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. | |
| 35626843 | Background |
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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.
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
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No masking is possible because caregivers must accept and comply a strict schedule of visits for three years. The dentists are aware of the participation to the protocol because they use additional supports and strategies, like a longer duration of the visit.
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| 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 |
| 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. |
| 35654391 | Background | 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. |
| 35232533 | Background | 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. |
| 31648672 | Background | 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. |