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

• Sponsor: Blekinge Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT05939050
• Collaborator: Kristianstad University (Other)
• Enrollment: 170
• Locations: 2
• Arm: 1
• Actual Duration (Months): 56
• Patients Per Site: 85
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oral Health; Quality of Life	Device: Powered toothbrush	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Jan 15, 2023
• Actual Study Completion Date: Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Partisipants	Device: Powered toothbrush; Oral-B Powered toothbrush

Outcome Measures

Primary Outcome Measures

1. Change in the amount of dental plaque [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Blekinge Institute of Technology	Karlskrona		Sweden	37179
2	Johan Flyborg	Karlskrona		Sweden	37179

Sponsors and Collaborators

• Blekinge Institute of Technology
• Kristianstad University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Blekinge Institute of Technology
• ClinicalTrials.gov Identifier: NCT05939050
• Other Study ID Numbers: BTH-6.1.1-0085-2023
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 11, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Blekinge Institute of Technology: Mild Cognitive Impairment; Oral Health; Quality of Life; Powered toothbrush
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Jul 11, 2023