跳至主要内容
临床试验/CTRI/2025/03/083013
CTRI/2025/03/083013尚未招募2/3 期

Comparing the effectiveness of three sided toothbrush vs traditional toothbrush in maintenance of oral hygiene among 4-6 year old children with Autism spectrum disorder in Hyderabad city.

Shweta kamble1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月4日最近更新:
适应症

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Plaque scores

研究概览

简要总结

People with autism spectrum disorder can experience many challenges that could affect their oral health status,including the need of assistance with core activities and barriers to quality health care.Factors that contribute to poor oral hygiene among this population include inadequate brushing technique,lack of caregiver training and adequate knowledge regarding the same ,so this study will be done to evaluate the effect of using a three-sided versus traditional toothbrush as an intervention to improve oral health of these children.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
4.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • •Mild to moderate ASD (autism spectrum disorder) children by using ISAA Scale score 70-153.

排除标准

  • •Severe autism cases.
  • •Children having decayed tooth or root stumps.

结局指标

主要结局

Plaque scores

时间窗: Baseline,3 weeks and 6 weeks

次要结局

  • Acceptability of toothbrush(At Baseline)

研究者

发起方
Shweta kamble
申办方类型
Private medical college

研究点 (1)

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