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临床试验/NCT05941611
NCT05941611已完成不适用

Results of Objective Brushing Data Recorded From a Powered Toothbrush Used by Elderly Individuals With Mild Cognitive Impairment Related to Values for Oral Health

Blekinge Institute of Technology2 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
213
试验地点
2
主要终点
Change in the number of brush sessions

研究概览

简要总结

For this study, 213 individuals were recruited. During the Baseline examination, each participant received a powered toothbrush and was carefully instructed on how to use the toothbrush and recommended using it for at least 2 minutes every morning and evening. No restrictions were imposed on the use of other oral health products. The study lasted from June 2018 to October 2020 and included a screening, a baseline examination, and additional reexaminations at 6 and 12 months. The Oral-B application was installed on the participant's mobile phones or computer tablets. Participants were instructed verbally and in writing on transferring data from the powered toothbrush to the application. The present study aimed to investigate how the true use of the powered toothbrush, in terms of frequency and duration, affects plaque index (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD) ≥4 mm in a group of elderly individuals with MCI. A second aim was to compare the registered time and brush frequencies to the individual's self-estimated usage of the powered toothbrushes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 55 years or older
  • Having experienced memory problems in the last six months before inclusion
  • Having a Mini-Mental State Examination score of 20-28
  • Are not receiving any formal care
  • Having at least ten teeth of their own

排除标准

  • Having a terminal illness with less than three years of expected survival
  • Having another known significant cause of disease explaining cognitive impairment

结局指标

主要结局

Change in the number of brush sessions

时间窗: From Baseline to month 6 and to month12

The number of uses of the toothbrush per day

Change in the amount of dental plaque

时间窗: From Baseline to month 6 and to month12

Plaque Index in percent

Change in the amount of gingival bleeding on probing

时间窗: From Baseline to month 6 and to month12

Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage

Change in the number of periodontal pockets 4 mm or deeper

时间窗: From Baseline to month 6 and to month12

The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage

Change of average brush time

时间窗: From Baseline to month 6 and to month12

The average time used for tooth brushing presented in min and sec.

次要结局

未报告次要终点

研究者

发起方
Blekinge Institute of Technology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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