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

Periodontal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05941611
• Other study ID #: BTH-6.1.1-0084-2023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: October 30, 2022

Study information

• Verified date: July 2023
• Source: Blekinge Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Periodontal Diseases

Intervention

Device:
• Powered toothbrush
Oral-B powered toothbrush

Locations

Country	Name	City	State
Sweden	Blekinge Institute of Technology	Karlskrona

Sponsors (2)

Lead Sponsor	Collaborator
Blekinge Institute of Technology	Kristianstad University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the amount of dental plaque	Plaque Index in percent	From Baseline to month 6 and to month12
Primary	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
Primary	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
Primary	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
Primary	Change in the number of brush sessions	The number of uses of the toothbrush per day	From Baseline to month 6 and to month12