NCT05939050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

4.6 years

First QC Date

June 13, 2023

Last Update Submit

July 2, 2023

Conditions

Oral HealthQuality of Life

Keywords

Mild Cognitive ImpairmentOral HealthQuality of LifePowered toothbrush

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Partisipants

EXPERIMENTAL
Device: Powered toothbrush

Interventions

Powered toothbrushDEVICE

Oral-B Powered toothbrush

Partisipants

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 55 years or older
  • Having a Mini-Mental State Examination score of 20-28
  • Are not receiving any formal care
  • Having at least ten teeth of their own

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Blekinge Institute of Technology

Karlskrona, 37179, Sweden

Location

Johan Flyborg

Karlskrona, 37179, Sweden

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Johan Sanmartin-Berglund, Professor

    Blekinge Institute of Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 11, 2023

Study Start

June 1, 2018

Primary Completion

January 15, 2023

Study Completion

January 30, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The trial protocol and the datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
Available after publication
Access Criteria
Available from the corresponding author upon reasonable request.

Locations

SE(2)