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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Oral Health
• Intervention / Treatment: Device: Powered toothbrush

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Karlskrona, Sweden, 37179
    • Blekinge Institute of Technology
  • Karlskrona, Sweden, 37179
    • Johan Flyborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partisipants	Device: Powered toothbrush; Oral-B Powered toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the amount of dental plaque	Presence of dental plaque measured on four of the tooth surfaces presented as a percentage	From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in the amount of gingival bleeding on probing	Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage	From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in the number of periodontal pockets 4 mm or deeper	The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage	From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in values for the quality of life instrument QoL-AD	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	From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in values for the oral health related quality of life instrument OHIP-14	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	From baseline, to month 6, and to month 12, and to month 24, and to month 36

Collaborators and Investigators

• Sponsor: Blekinge Institute of Technology
• Collaborators: Kristianstad University
• Investigators: Study Chair: Johan Sanmartin-Berglund, Professor, Blekinge Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Mild Cognitive Impairment; Oral Health; Powered toothbrush
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: BTH-6.1.1-0085-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial protocol and the datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: Available after publication
• IPD Sharing Access Criteria: Available from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No