NCT07261670已完成不适用
A Comparative Study of Virtual Reality and Sensory-Adapted Dental Environments for Dental Anxiety Reduction in Individuals With Borderline Intellectual Functioning
Oasi Research Institute-IRCCS2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年6月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Treatment success
研究概览
简要总结
A randomized clinical trial was conducted with 98 participants with borderline intellectual functioning (BIF) and moderate dental anxiety (DAS: 9-12). Participants were assigned in a 1:1 ratio to either the Virtual reality (VR) or sensory adapted dentist environment (SADE) group (49 per group). The primary outcome was treatment success, defined as completing a dental restoration under local anesthesia within 30 minutes.
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
- 11 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of participants between 10 and 13 years
- •Diagnosis of Borderline Intellectual Func-tioning (BIF) confirmed by experienced neuropsychiatrists according to DSM-5 criteria
- •Moderate dental anxiety, defined by a DAS score between 9 and 12
- •Presence of at least one tooth with a Class I carious lesion requiring restorative treatment
排除标准
- •absence of dental anxiety (DAS score = 4)
- •the presence of mild anxiety (DAS score = 5-8)
- •high or severe anxiety (DAS score ≥ 13)
结局指标
主要结局
Treatment success
时间窗: Duration of procedure
Completion of restorative dental procedure under local anesthesia within 30 minutes and positive overall treatment experience (dichotomous: success vs. failure)
次要结局
未报告次要终点
研究者
研究点 (2)
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