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

Primary Purpose

Gingivitis, Periodontal Diseases

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Powered toothbrush

About this trial

This is an interventional basic science trial for Gingivitis focused on measuring Mild Cognitive Impairment, Oral Health, Powered toothbrush

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Blekinge Institute of Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Partisipants

Arm Description

Outcomes

Primary Outcome Measures

Change in the amount of dental plaque

Plaque Index in percent

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

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

Change of average brush time

The average time used for tooth brushing presented in min and sec.

Change in the number of brush sessions

The number of uses of the toothbrush per day

Secondary Outcome Measures

Full Information

NCT ID

NCT05941611

First Posted

June 13, 2023

Last Updated

July 11, 2023

Sponsor

Blekinge Institute of Technology

Collaborators

Kristianstad University

1. Study Identification

Unique Protocol Identification Number

NCT05941611

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

October 30, 2022 (Actual)

Study Completion Date

October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Blekinge Institute of Technology

Collaborators

Kristianstad University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis, Periodontal Diseases

Keywords

Mild Cognitive Impairment, Oral Health, Powered toothbrush

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

213 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Partisipants

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Powered toothbrush

Intervention Description

Oral-B powered toothbrush

Primary Outcome Measure Information:

Title

Change in the amount of dental plaque

Description

Plaque Index in percent

Time Frame