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

Sponsor
Blekinge Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT05941611
Collaborator
Kristianstad University (Other)
213
1
1
53
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Powered toothbrush
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
213 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Oct 30, 2022
Actual Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Partisipants

Device: Powered toothbrush
Oral-B powered toothbrush

Outcome Measures

Primary Outcome Measures

  1. Change in the amount of dental plaque [From Baseline to month 6 and to month12]

    Plaque Index in percent

  2. Change in the amount of gingival bleeding on probing [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 [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 [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 [From Baseline to month 6 and to month12]

    The number of uses of the toothbrush per day

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blekinge Institute of Technology Karlskrona Sweden 37179

Sponsors and Collaborators

  • Blekinge Institute of Technology
  • Kristianstad University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blekinge Institute of Technology
ClinicalTrials.gov Identifier:
NCT05941611
Other Study ID Numbers:
  • BTH-6.1.1-0084-2023
First Posted:
Jul 12, 2023
Last Update Posted:
Jul 12, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Blekinge Institute of Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2023