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

Primary Purpose

Autism Spectrum Disorder

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Behavioral support

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Dentistry

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Piove di Sacco Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral support

Control No behavioral support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Collaboration

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

Secondary Outcome Measures

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Acceptance

Acceptance of every action or instrument: Yes/No

Full Information

NCT ID

NCT05553262

First Posted

September 14, 2022

Last Updated

September 23, 2022

Sponsor

University of Padova

Collaborators

ULSS 6 Euganea, Nastrificio Victor S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT05553262

Brief Title

A Protocol to Streamline Dental Care in Autistic Children

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Padova

Collaborators

ULSS 6 Euganea, Nastrificio Victor S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Autism, Dentistry

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking Description

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.

Allocation

Non-Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Behavioral support

Arm Type

Experimental

Arm Description

Arm Title

Control No behavioral support

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral support

Intervention Description

Behavioral support as described under 'Arm description'.

Primary Outcome Measure Information:

Title

Collaboration

Description

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

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.

Secondary Outcome Measure Information:

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 1, month 2

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 1, month 4

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 1, month 6

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 1, month 8

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 1, month 10

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 1, month 12

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 2, month 2

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 2, month 4

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 2, month 6

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 2, month 8

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 2, month 10

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 2, month 12

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 3, month 2

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 3, month 4

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 3, month 6

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 3, month 8

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 3, month 10

Title

Acceptance

Description

Acceptance of every action or instrument: Yes/No

Time Frame

Year 3, month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carla Mucignat, Ph.D.

Organizational Affiliation

University of Padova

Official's Role

Principal Investigator

Facility Information:

Facility Name

Piove di Sacco Hospital

City

Piove Di Sacco

State/Province

ZIP/Postal Code

35028

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

PubMed Identifier

35524299

Citation

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.

Results Reference

background

PubMed Identifier

35626843

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):666. doi: 10.3390/children9050666.

Results Reference

background

PubMed Identifier

35654391

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. 2023 Jan;43(1):17-28. doi: 10.1111/scd.12746. Epub 2022 Jun 2.

Results Reference

background

PubMed Identifier

35232533

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.

Results Reference

background

PubMed Identifier

31648672

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.

Results Reference

background

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A Protocol to Streamline Dental Care in Autistic Children

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