The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment

NCT ID: NCT05939050

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2023-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Health Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Partisipants

Group Type EXPERIMENTAL

Powered toothbrush

Intervention Type DEVICE

Oral-B Powered toothbrush

Interventions

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Powered toothbrush

Oral-B Powered toothbrush

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kristianstad University

OTHER

Sponsor Role collaborator

Blekinge Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Sanmartin-Berglund, Professor

Role: STUDY_CHAIR

Blekinge Institute of Technology

Locations

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Blekinge Institute of Technology

Karlskrona, , Sweden

Site Status

Johan Flyborg

Karlskrona, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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BTH-6.1.1-0085-2023

Identifier Type: -

Identifier Source: org_study_id

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