Skip to main content
OpenTrials
Completed

NCT Number: NCT05939050

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oral Health Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Quality of Life

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blekinge Institute of Technology, Karlskrona, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Powered toothbrush

Device

Oral-B Powered toothbrush

Primary outcomes

  1. Change in the amount of dental plaque

    Time frame: 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

  2. Change in the amount of gingival bleeding on probing

    Time frame: 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

  3. Change in the number of periodontal pockets 4 mm or deeper

    Time frame: 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

  4. Change in values for the quality of life instrument QoL-AD

    Time frame: 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

  5. Change in values for the oral health related quality of life instrument OHIP-14

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Blekinge Institute of Technology

Other

Collaborators

  • Kristianstad University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2023
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.