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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Collaboration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Collaboration
时间窗: 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)
次要结局
- Acceptance(Year 3, month 12)
研究者
MUCIGNAT CARLA
Principal Investigator
University of Padova