NCT06011564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

4.6 years

First QC Date

June 12, 2023

Last Update Submit

August 21, 2023

Conditions

Mild Cognitive ImpairmentGingivitisPeriodontal Diseases

Keywords

Mild Cognitive ImpairmentOral HealthQuality of Life

Outcome Measures

Primary Outcomes (5)

  • Change in the amount of dental plaque

    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

    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

    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

    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

    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

Study Arms (2)

Intervention

EXPERIMENTAL

Reminder function

Device: Reminder function on Android computer tablet

control

NO INTERVENTION

No reminder

Interventions

Reminder function on Android computer tabletDEVICE

Computer tablet with reminder function

Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 55 years or older
  • Having a Mini-Mental State Examination score of 20-28
  • Are not receiving any formal care
  • Having at least ten teeth of their own

You may not qualify if:

  • Having a terminal illness with less than three years of expected survival
  • Having another known significant cause of disease explaining cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blekinge Institute of Technology

Karlskrona, 37179, Sweden

Location

MeSH Terms

Conditions

Cognitive DysfunctionGingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersInfectionsGingival DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Johan Sanmartin-Berglund, Professor

    Blekinge Institute of Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

August 25, 2023

Study Start

June 1, 2018

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

The trial protocol and the datasets used and analyzed during the current study are available upon reasonable request.

Shared Documents
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.

Locations

SE(1)