Results From Objective Brushing Data Saved From a Powered Toothbrush Related to Values for Oral Health

July 11, 2023 updated by: Blekinge Institute of Technology

Results of Objective Brushing Data Recorded From a Powered Toothbrush Used by Elderly Individuals With Mild Cognitive Impairment Related to Values for Oral Health

For this study, 213 individuals were recruited. During the Baseline examination, each participant received a powered toothbrush and was carefully instructed on how to use the toothbrush and recommended using it for at least 2 minutes every morning and evening. No restrictions were imposed on the use of other oral health products. The study lasted from June 2018 to October 2020 and included a screening, a baseline examination, and additional reexaminations at 6 and 12 months. The Oral-B application was installed on the participant's mobile phones or computer tablets. Participants were instructed verbally and in writing on transferring data from the powered toothbrush to the application. The present study aimed to investigate how the true use of the powered toothbrush, in terms of frequency and duration, affects plaque index (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD) ≥4 mm in a group of elderly individuals with MCI. A second aim was to compare the registered time and brush frequencies to the individual's self-estimated usage of the powered toothbrushes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From Baseline to month 6 and to month12
Plaque Index in percent
From Baseline to month 6 and to month12
Change in the amount of gingival bleeding on probing
Time Frame: From Baseline to month 6 and to month12
Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage
From Baseline to month 6 and to month12
Change in the number of periodontal pockets 4 mm or deeper
Time Frame: From Baseline to month 6 and to month12
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 month12
Change of average brush time
Time Frame: From Baseline to month 6 and to month12
The average time used for tooth brushing presented in min and sec.
From Baseline to month 6 and to month12
Change in the number of brush sessions
Time Frame: From Baseline to month 6 and to month12
The number of uses of the toothbrush per day
From Baseline to month 6 and to month12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blekinge Institute of Technology

Collaborators

Kristianstad University

Investigators

  • Study Chair: Johan Sanmartin-Berglund, Professor, Blekinge Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTH-6.1.1-0084-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Starting after publication

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe