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临床试验/CTRI/2025/07/090362
CTRI/2025/07/090362已完成不适用

Effect of Oral Health Education on Salivary Microorganisms in Children with Autism Spectrum Disorder

Dr N J Remya1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月17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
10
试验地点
1
主要终点
Total plate count

研究概览

简要总结

Children were asked to wash mouth and avoid eating or drinking for 1 hour, following which, approximately 1 ml of non-stimulated, naturally outflowed saliva sample was collected from the children using the saliva collection kit. The sample collected was stored in containers along with ice pack to maintain the cold temperature. Oral health education was done using dental models, picture cards, videos, etc. The collected sample were transported to the lab, the same day and each sample was evaluated for total microbial count, using the microbial method called total plate count.

Oral health education was given again at 3 months and 6 months and Post intervention saliva samples are to be  collected and evaluated at 12 months.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Children with Autism Spectrum Disorder.
  • Mild to moderate. Children in primary and mixed dentition period.

排除标准

  • Autistic children presenting aggressive behaviour.
  • Children with serious systemic conditions.
  • Children with any comorbidities that restrict their participation in the study.

结局指标

主要结局

Total plate count

时间窗: baseline | 12 months

次要结局

未报告次要终点

研究者

发起方
Dr N J Remya
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

Dr N J Remya

Amrita School of Dentistry

研究点 (1)

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