NCT05941611

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

4.4 years

First QC Date

June 13, 2023

Last Update Submit

July 11, 2023

Conditions

GingivitisPeriodontal Diseases

Keywords

Mild Cognitive ImpairmentOral HealthPowered toothbrush

Outcome Measures

Primary Outcomes (5)

  • Change in the amount of dental plaque

    Plaque Index in percent

    From Baseline to month 6 and to month12

  • 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 month12

  • 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 month12

  • Change of average brush time

    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

    The number of uses of the toothbrush per day

    From Baseline to month 6 and to month12

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 (1)

Blekinge Institute of Technology

Karlskrona, 37179, Sweden

Location

Related Publications (1)

  • Flyborg J, Renvert S, Anderberg P, Larsson T, Sanmartin-Berglund J. Results of objective brushing data recorded from a powered toothbrush used by elderly individuals with mild cognitive impairment related to values for oral health. Clin Oral Investig. 2023 Dec 21;28(1):8. doi: 10.1007/s00784-023-05407-2.

    PMID: 38123762DERIVED

MeSH Terms

Conditions

GingivitisPeriodontal DiseasesCognitive Dysfunction

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesMouth DiseasesStomatognathic DiseasesCognition 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 12, 2023

Study Start

June 1, 2018

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Starting after publication
Access Criteria
The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.

Locations

SE(1)