NCT07413016已完成不适用
Comparison of Sensory-Adapted (SADE) and Regular Dental Environments (RDE) in Patients With Mild Intellectual Disability and Moderate Dental Anxiety
Oasi Research Institute-IRCCS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月2日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Treatment success
研究概览
简要总结
This study compared a sensory-adapted dental environment (SADE) with a regular dental environment (RDE) in 6-7-year-old children with mild intellectual disability and moderate dental anxiety. The objective was to determine which approach more effectively facilitates the completion of dental polishing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-7; diagnosis of mild intellectual disability (DSM-5) Moderate anxiety (Corah DAS 9-12)
- •Informed consent from parents/legal guardians
排除标准
- •no or slight anxiety
- •high or severe anxiety
- •visual disorders
- •neuromuscular comorbidities interfering with cooperation
研究组 & 干预措施
Regular dental environment (RDE)
Active Comparator
干预措施: RDE (Other)
Sensory adapted dental environment (SADE)
Experimental
干预措施: SADE (Other)
结局指标
主要结局
Treatment success
时间窗: 25 minutes
Number of patients with completion of dental polishing under local anesthesia within 25 minutes (dichotomous: success vs. failure)
次要结局
未报告次要终点
研究者
研究点 (1)
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