eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age
Primary Purpose
Mild Cognitive Impairment, Gingivitis, Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Reminder function on Android computer tablet
Sponsored by
About this trial
This is an interventional basic science trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Oral Health, Quality of Life
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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
control
Arm Description
Reminder function
No reminder
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
NCT06011564
First Posted
June 12, 2023
Last Updated
August 21, 2023
Sponsor
Blekinge Institute of Technology
Collaborators
Kristianstad University
1. Study Identification
Unique Protocol Identification Number
NCT06011564
Brief Title
eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age
Official Title
eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will present a new strategy for working with oral health for the group of elderly people with various degrees of mild cognitive impairments. The investigators hope that by introducing a powered toothbrush with functions that make it possible to remind and gather information about the use, the investigators will primarily facilitate oral care for this group, and are proposing that this will lead to higher quality of life of the persons involved.
Detailed Description
The investigators will present a new strategy for working with oral health for the group of elderly people with various degrees of mild cognitive impairments. The investigators hope that by introducing a powered toothbrush with functions that make it possible to remind and gather information about use, the investigators will primarily facilitate oral care for this group, and are proposing that this will lead to higher quality of life of the persons involved. Secondarily this will have great impact on the care/carer situation as well as the need for reactive dental care. Expected results is to see both how the actual reminders can be designed in order to accommodate for this group, the context of how these reminders can be used and ultimately if this has an impact on oral health for the group of elderly people with various degrees of mild cognitive impairments.
With age, functional decline occurs and the incidence and prevalence of chronic diseases increase, so aging is an important risk for developing medical conditions. Along with age, the prevalence of dementia increases significantly.
Persons with dementia show a higher prevalence of coronal and root caries and present more often with root remnants as the utilization of dental services becomes scarce. Patients with dementia had an increased likelihood of tooth loss and untreated caries, as well as
presenting with poor oral and denture hygiene compared with non-demented persons. In the initial stages of the disease, this condition may be related to a shift in priorities and a reluctance to brush the teeth. In addition, there is the inability to accurately perform oral hygiene measures due to poor motor skills and sacropenia, especially of the hand-grip strength, render oral hygiene measures more difficult to perform. When the disease progresses, patients will become increasingly dependent on supervision/assistance on oral hygiene procedures. Co-operation is required when a carer has to perform oral hygiene measures and access to the mouth has to be granted. Poor oral hygiene and the presence of abundant biofilm fosters periodontal disease and caries. Combined with a shift in dietary intake towards more sweet food-stuffs the risk factors for developing carious lesions increases significantly. The risk of caries is further increased as result of a decreased salivary flow due to medication intake.
Previous research has demonstrated that the use of a powered toothbrush instead of a manual one reduces plaque and gingivitis more effectively than manual toothbrushes . The reduction of gingivitis using an electric toothbrush as compared to a manual one is reported to be in the range of 11 to 17%. According to the American Dental association tooth brushing should be performed twice daily for two minutes each time. On average it is estimated that people brush their teeth for less than a minute per day. The efficacy of a toothbrush is highly dependent on how long time the individual is actually using the device and it can be anticipated that individuals with mild cognitive impairment may forget to use the tooth brush on a daily basis and also that whenever using the brush the time spent may be even shorter than 30 seconds each time. The control group will be supplied with a powered toothbrush only and instructed to use any other means of tooth cleaning (ie. interdental cleaning) as before. It is anticipated that a temporary improvement of oral hygiene will occur in the control group, but the temporary improvement may not be sustainable among individuals with mild cognitive impairment. Accordingly, there will not be an added benefit for either the individual or the society only to supply individuals with cognitive impairment with a powered toothbrush.
In the test group, individuals are supplied with a powered toothbrush and a tablet with reminder functions. It is anticipated that the brush will be used more frequently and possibly also for longer periods compared to the group without such reminder functions, resulting in >30% improvement compared to the control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Gingivitis, Periodontal Diseases
Keywords
Mild Cognitive Impairment, Oral Health, Quality of Life
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Reminder function
Arm Title
control
Arm Type
No Intervention
Arm Description
No reminder
Intervention Type
Device
Intervention Name(s)
Reminder function on Android computer tablet
Intervention Description
Computer tablet with reminder function
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
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 upon reasonable request.
IPD Sharing Time Frame
From 2023-06-12
IPD Sharing Access Criteria
The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.
Learn more about this trial
eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age
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