The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment

Quality of Life Clinical Trial

Official title:

The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939050
• Other study ID #: BTH-6.1.1-0085-2023
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: July 2023
• Source: Blekinge Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 30, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Oral Health
• Quality of Life

Intervention

Device:
• Powered toothbrush
Oral-B Powered toothbrush

Locations

Country	Name	City	State
Sweden	Blekinge Institute of Technology	Karlskrona
Sweden	Johan Flyborg	Karlskrona

Sponsors (2)

Lead Sponsor	Collaborator
Blekinge Institute of Technology	Kristianstad University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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