Back to resultsThe Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment
Primary Purpose
Oral Health, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Powered toothbrush
Sponsored by
About this trial
This is an interventional basic science trial for Oral Health focused on measuring Mild Cognitive Impairment, Oral Health, Quality of Life, Powered toothbrush
Eligibility Criteria
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
- Johan Flyborg
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
Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
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 in values for the quality of life instrument QoL-AD
The value for the quality of life instrument QoL-AD (Quality of Life Alzheimer Disease) is measured on a scale from 0-30, where 30 corresponds to the highest quality of life
Change in values for the oral health related quality of life instrument OHIP-14
The value for the oral health-related quality of life instrument OHIP-14 (Oral Health Impact Profile-14) is measured on a scale from 0-56 where 0 corresponds to the highest quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT05939050
First Posted
June 13, 2023
Last Updated
July 2, 2023
Sponsor
Blekinge Institute of Technology
Collaborators
Kristianstad University
1. Study Identification
Unique Protocol Identification Number
NCT05939050
Brief Title
The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment
Official Title
The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial
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
January 15, 2023 (Actual)
Study Completion Date
January 30, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
For this study, 213 individuals with Mild Cognitive Impairment were recruited. The study period ran from June 2018 to October 2021. The procedure involved a combined screening and baseline examination, including oral, medical, cognitive, and quality-of-life examinations. Re-examinations followed this at 6, 12, and 24 months. The examinations were performed at a university research clinic, and all participants received their usual medical and dental care during the study. At baseline, each participant received a powered toothbrush. Participants were carefully instructed on how to operate the powered toothbrush and were asked to brush for at least two minutes in the morning and evening. No restrictions were given against the use of other oral care products. Compliance with the powered toothbrush was followed by a participant survey conducted at each examination.. Facilitating and improving life by introducing a powered toothbrush as part of oral hygiene may benefit individuals with MCI. This study aimed to investigate whether the use of a powered toothbrush could maintain or improve oral health by reducing dental plaque (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD)≥4mm in a group of individuals with MCI for an observation period of 24 months. Furthermore, to study how oral health changes affect QoL aspects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Health, Quality of Life
Keywords
Mild Cognitive Impairment, Oral Health, Quality of Life, 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
170 (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
Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
Time Frame
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Title
Change in the amount of gingival bleeding on probing
Description
Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage
Time Frame
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Title
Change in the number of periodontal pockets 4 mm or deeper
Description
The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage
Time Frame
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Title
Change in values for the quality of life instrument QoL-AD
Description
The value for the quality of life instrument QoL-AD (Quality of Life Alzheimer Disease) is measured on a scale from 0-30, where 30 corresponds to the highest quality of life
Time Frame
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Title
Change in values for the oral health related quality of life instrument OHIP-14
Description
The value for the oral health-related quality of life instrument OHIP-14 (Oral Health Impact Profile-14) is measured on a scale from 0-56 where 0 corresponds to the highest quality of life
Time Frame
From baseline, to month 6, and to month 12, and to month 24, and to month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Sanmartin-Berglund, Professor
Organizational Affiliation
Blekinge Institute of Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Blekinge Institute of Technology
City
Karlskrona
ZIP/Postal Code
37179
Country
Sweden
Facility Name
Johan Flyborg
City
Karlskrona
ZIP/Postal Code
37179
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The trial protocol and the datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
IPD Sharing Time Frame
Available after publication
IPD Sharing Access Criteria
Available from the corresponding author upon reasonable request.
Learn more about this trial
The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment
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