Effect of Sensory Adapted Dental Environment on Dental Anxiety of Children With Intellectual and Developmental Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Behavior during initial dental exam
研究概览
简要总结
Children with intellectual/developmental disabilities (ID/DD) will experience less dental anxiety and cooperate better in a Sensory Adapted Dental Environment (modified visual, sensory, and somatosensory stimuli in a regular dental setting) than in a regular dental environment (RDE).
详细描述
The aim of this pilot study is to determine the effect of sensory adapted dental environment (SADE) on reducing dental anxiety of children with intellectual and/or developmental disabilities (ID/DD). With the growing number of children diagnosed with ID/DD and their inclusion in the community, there are more opportunities for dentists to encounter this population for their routine oral health care. If improvement in dental anxiety and behavior is evident from the study, as other pilot studies have suggested, it can be applied as one of clinical tools for treating children with ID/DDs. Furthermore, utilization of a SADE in clinical training of pediatric dentists or general dentists can improve clinicians' comfort level in managing behavior of individuals with ID/DD. This will encourage more clinicians to provide care and address the unmet oral health needs of this vulnerable population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with intellectual and/or developmental disabilities
排除标准
- •No specific diagnosis
- •Parents/guardians have limited English proficiency
研究组 & 干预措施
Group 2
Sensory adapted dental environment (SADE) at recall exam (visit 2)
干预措施: Sensory Adapted Dental Environment (SADE) (Behavioral)
Group 1
Sensory adapted dental environment (SADE) at first exam (visit 1)
干预措施: Sensory Adapted Dental Environment (SADE) (Behavioral)
结局指标
主要结局
Behavior during initial dental exam
时间窗: Day 1
Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5=definitely positive
Behavior during recall exam
时间窗: 3 months
Measured using Frankl Scale for pediatric dentistry, with 1=definitely negative and 5= definitely positive
次要结局
- Patient cooperation during recall exam(3 months)
- Physiologic outcomes (hearts rate) during initial exam(3 months)
- Physiologic outcomes (oxygen saturation) during initial exam(Day 1)
- Physiologic outcomes (oxygen saturation) during recall exam(3 months)
- Patient cooperation during initial exam(Day 1)