The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Change in values for the quality of life instrument QoL-AD
研究概览
简要总结
For this study, 213 individuals with Mild Cognitive Impairment were recruited. The study period ran from June 2018 to October 2021. The procedure involved a combined screening and baseline examination, including oral, medical, cognitive, and quality-of-life examinations. Re-examinations followed this at 6, 12, and 24 months. The examinations were performed at a university research clinic, and all participants received their usual medical and dental care during the study. At baseline, each participant received a powered toothbrush. Participants were carefully instructed on how to operate the powered toothbrush and were asked to brush for at least two minutes in the morning and evening. No restrictions were given against the use of other oral care products. Compliance with the powered toothbrush was followed by a participant survey conducted at each examination.. Facilitating and improving life by introducing a powered toothbrush as part of oral hygiene may benefit individuals with MCI. This study aimed to investigate whether the use of a powered toothbrush could maintain or improve oral health by reducing dental plaque (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD)≥4mm in a group of individuals with MCI for an observation period of 24 months. Furthermore, to study how oral health changes affect QoL aspects.
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
- 否
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 values for the quality of life instrument QoL-AD
时间窗: From baseline, to month 6, and to month 12, and to month 24, and to month 36
The value for the quality of life instrument QoL-AD (Quality of Life Alzheimer Disease) is measured on a scale from 0-30, where 30 corresponds to the highest quality of life
Change in values for the oral health related quality of life instrument OHIP-14
时间窗: From baseline, to month 6, and to month 12, and to month 24, and to month 36
The value for the oral health-related quality of life instrument OHIP-14 (Oral Health Impact Profile-14) is measured on a scale from 0-56 where 0 corresponds to the highest quality of life
Change in the amount of gingival bleeding on probing
时间窗: From baseline, to month 6, and to month 12, and to month 24, and to month 36
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 month 12, and to month 24, and to month 36
The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage
Change in the amount of dental plaque
时间窗: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
次要结局
未报告次要终点