eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age

August 21, 2023 updated by: Blekinge Institute of Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Karlskrona, Sweden, 37179
        • Blekinge Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Reminder function
Device: Reminder function on Android computer tablet
Computer tablet with reminder function
No Intervention: control
No reminder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the amount of dental plaque
Time Frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in the amount of gingival bleeding on probing
Time Frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Number of bleeding from the gingiva measured on four sides of the teeth presented as a percentage
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in the number of periodontal pockets 4 mm or deeper
Time Frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
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 month 12, and to month 24, and to month 36
Change in values for the quality of life instrument QoL-AD
Time Frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
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
From baseline, to month 6, and to month 12, and to month 24, and to month 36
Change in values for the oral health related quality of life instrument OHIP-14
Time Frame: From baseline, to month 6, and to month 12, and to month 24, and to month 36
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
From baseline, to month 6, and to month 12, and to month 24, and to month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blekinge Institute of Technology

Collaborators

Kristianstad University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTH-6.1.1-0059-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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