Oral HealthNCT05939050
The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment
A study testing Powered toothbrush in people with Oral Health and Quality of Life, run by Blekinge Institute of Technology at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Oral Health, Quality of Life
- What is being tested?
- Powered toothbrush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jun 2018to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having a terminal illness with less than three years of expected survival
- Having another known significant cause of disease explaining cognitive impairment
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Blekinge Institute of Technology
Karlskrona, 37179
Johan Flyborg
Karlskrona, 37179
About this study
Official title: The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial
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.
- Conditions
- Oral Health, Quality of Life
- Being tested
- Powered toothbrush
- Keywords
- Mild Cognitive Impairment, Oral Health, Quality of Life, Powered toothbrush
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered toothbrushDevice
Oral-B Powered toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Partisipants | Experimental | Not described Receives: Device: Powered toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the amount of dental plaque
Presence of dental plaque measured on four of the tooth surfaces presented as a percentage
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline, to month 6, and to month 12, and to month 24, and to month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jun 2018
- Primary completion15 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blekinge Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Kristianstad University
- Responsible party
- Sponsor
- Investigators
- Johan Sanmartin-Berglund, Professor, Study chair, Blekinge Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939050
- Sponsor's protocol ID
- BTH-6.1.1-0085-2023
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The trial protocol and the datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
Publications
Flyborg J, Renvert S, Anderberg P, Sanmartin-Berglund J. The long-term effect on oral health and quality of life using a powered toothbrush in individuals with mild cognitive impairment. An intervention trial. Spec Care Dentist. 2024 Nov-Dec;44(6):1700-1708. doi: 10.1111/scd.13040. Epub 2024 Jul 12.
PubMed 38994574
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effect on Oral Health Using a Powered Toothbrush in Individuals With Mild Cognitive Impairment: An Intervention Trial
- ClinicalTrials.gov ID
- NCT05939050
- Acronym / sponsor ID
- BTH-6.1.1-0085-2023
- Conditions
- Oral Health, Quality of Life
- Keywords
- Mild Cognitive Impairment, Oral Health, Quality of Life, Powered toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Blekinge Institute of TechnologyUniversity, hospital or other
- Collaborators
- Kristianstad University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partisipants | Experimental | Device: Powered toothbrush |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Having a terminal illness with less than three years of expected survival
- Having another known significant cause of disease explaining cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered toothbrushOral-B Powered toothbrush | Device | Partisipants |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 38994574Flyborg J, Renvert S, Anderberg P, Sanmartin-Berglund J. The long-term effect on oral health and quality of life using a powered toothbrush in individuals with mild cognitive impairment. An intervention trial. Spec Care Dentist. 2024 Nov-Dec;44(6):1700-1708. doi: 10.1111/scd.13040. Epub 2024 Jul 12.
- Individual participant dataSharing planned: Yes. The trial protocol and the datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Sanmartin-Berglund, Professor study chair
Blekinge Institute of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered toothbrush in people with Oral Health and Quality of Life, run by Blekinge Institute of Technology at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05939050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.