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

• ClinicalTrials.gov Identifier: NCT06011564
• Recruitment Status: Completed
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Sponsor: Blekinge Institute of Technology
• Collaborator: Kristianstad University
• Information provided by (Responsible Party): Blekinge Institute of Technology

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.

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment; Gingivitis; Periodontal Diseases	Device: Reminder function on Android computer tablet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 213 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: RCT
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: eDENT Oral Health- the Gateway to Quality of Care and Everyday Life at Old Age
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: January 15, 2023
• Actual Study Completion Date: January 15, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Reminder function	Device: Reminder function on Android computer tablet; Computer tablet with reminder function
No Intervention: control; No reminder

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Blekinge Institute of Technology

Karlskrona, Sweden, 37179

Sponsors and Collaborators

Blekinge Institute of Technology

Kristianstad University

Investigators

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

More Information

• Responsible Party: Blekinge Institute of Technology
• ClinicalTrials.gov Identifier: NCT06011564
• Other Study ID Numbers: BTH-6.1.1-0059-2016
• First Posted: August 25, 2023
• Last Update Posted: August 25, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.
• Supporting Materials: Study Protocol
• Time Frame: From 2023-06-12
• Access Criteria: The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.

• 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

Keywords provided by Blekinge Institute of Technology:

Mild Cognitive Impairment; Oral Health; Quality of Life

Additional relevant MeSH terms:

Gingivitis; Periodontal Diseases; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases