Clinical trial NCT05939050: The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment
Official title: The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Quality of Life
Keywords: Mild Cognitive Impairment
Oral Health
Quality of Life
Powered toothbrush
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
Collaborators: name: Kristianstad University
First posted: 2023-07-11
Enrollment: 170
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in the amount of dental plaque
timeFrame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
measure: Change in the amount of gingival bleeding on probing
timeFrame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
measure: Change in the number of periodontal pockets 4 mm or deeper
timeFrame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
measure: Change in values for the quality of life instrument QoL-AD
timeFrame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
measure: Change in values for the oral health related quality of life instrument OHIP-14
timeFrame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge Institute of Technology
city: Karlskrona
country: Sweden
facility: Johan Flyborg
Study officials:
affiliation: Blekinge Institute of Technology
name: Johan Sanmartin-Berglund, Professor
role: STUDY_CHAIR
References: