跳至主要内容
临床试验/CTRI/2024/03/064436
CTRI/2024/03/064436招募中3 期

Evaluation of the effect of night time brushing on sleep quality using Mat-type sleep analyzer: A Randomized Controlled Trial

Army Dental Centre Research and Referral1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月10日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
1. To determine whether night-time brushing improves sleep quality.

研究概览

简要总结

Sleep, a fundamental and complex physiological process, is integral to overall well-being, with its significance extending beyond the realms of rest and rejuvenation. Concurrently, oral health, encompassing the condition of the oral cavity and its structures, plays a pivotal role in an individual’s general health status. While these two domains may appear disparate at first glance, the evidence suggests a multifaceted relationship, whereby disturbances in one may significantly impact the other. Effect of sleep on oral health has been studied and documented, but the converse has not been focused. Research on the impact of oral biome-brain axis is still in the nascent stage. Understanding the intricate relationship between sleep quality and oral health holds significant clinical and public health implications. Unraveling the underlying mechanisms and identifying potential intervention strategies could pave the way for comprehensive approaches to improve both sleep quality and oral health, ultimately enhancing overall well-being. The proposed study will be carried out to assess the effect of night-time brushing on sleep quality of 80 healthy children between 08-18 years of age using under-the-mattress sleep analyzer.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
8.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children who don’t brush at night.
  • Children not experiencing sleep disturbances or suboptimal sleep quality, as indicated by self-report (The Pittsburgh sleep quality index).
  • Participants should not have any significant underlying medical conditions that could affect sleep quality (e.g., chronic pain, respiratory disorders, psychiatric disorders).
  • Participants must be committed to attending follow-up assessments and adhering to the study protocol.

排除标准

  • Individuals with diagnosed sleep disorders.
  • Individuals currently using prescription sleep medications or other substances that could significantly affect sleep quality.
  • Individuals with physical disabilities that could hinder the proper use of the Sleep Analyzer.
  • Individuals who have undergone recent oral surgeries, extractions, or dental procedures that could affect their ability to adhere to oral hygiene interventions.
  • Individuals participating in other clinical trials or studies that could interfere with the results of the current study.

结局指标

主要结局

1. To determine whether night-time brushing improves sleep quality.

时间窗: 24 months

2. To determine if there is a significant difference in sleep quality after night-time brushing.

时间窗: 24 months

次要结局

  • Correlation between night time brushing and sleep quality(24 months)

研究者

发起方
Army Dental Centre Research and Referral
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Vineet Sharma

Army Dental Centre (Research and Referral)

研究点 (1)

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