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OpenTrials
Completed

NCT Number: NCT05941611

Results From Objective Brushing Data Saved From a Powered Toothbrush 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.

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Key information

Conditions

Gingivitis Cognition Disorders Cognitive Dysfunction Gingival Diseases Infections Mental Disorders Mouth Diseases Neurocognitive Disorders Periodontal Diseases Stomatognathic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blekinge Institute of Technology

Karlskrona, 37179, Sweden

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 month12

    Plaque Index in percent

  2. 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

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Blekinge Institute of Technology

Other

Collaborators

  • Kristianstad University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2023
Registry last updated
Jul 12, 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.

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