GingivitisNCT05941611
Results From Objective Brushing Data Saved From a Powered Toothbrush Related to Values for Oral Health
A study testing Powered toothbrush in people with Gingivitis and Periodontal Diseases, run by Blekinge Institute of Technology at 1 site in Sweden.
Trial summary
For this study, 213 individuals were recruited. During the Baseline examination, each participant received a powered toothbrush and was carefully instructed on how to use the toothbrush and recommended using it for at least 2 minutes every morning and evening. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Gingivitis, Periodontal Diseases
- 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
- 213 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2018to 30 Oct 2022
- 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
1 site in 1 country.
About this study
Official title: Results of Objective Brushing Data Recorded From a Powered Toothbrush Used by Elderly Individuals With Mild Cognitive Impairment Related to Values for Oral Health
For this study, 213 individuals were recruited. During the Baseline examination, each participant received a powered toothbrush and was carefully instructed on how to use the toothbrush and recommended using it for at least 2 minutes every morning and evening. No restrictions were imposed on the use of other oral health products. The study lasted from June 2018 to October 2020 and included a screening, a baseline examination, and additional reexaminations at 6 and 12 months. The Oral-B application was installed on the participant's mobile phones or computer tablets. Participants were instructed verbally and in writing on transferring data from the powered toothbrush to the application. The present study aimed to investigate how the true use of the powered toothbrush, in terms of frequency and duration, affects plaque index (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD) ≥4 mm in a group of elderly individuals with MCI. A second aim was to compare the registered time and brush frequencies to the individual's self-estimated usage of the powered toothbrushes.
- Conditions
- Gingivitis, Periodontal Diseases
- Being tested
- Powered toothbrush
- Keywords
- Mild Cognitive Impairment, Oral Health, Powered toothbrush
- Medical subject headings
- Gingivitis, Periodontal Diseases, 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
Plaque Index in percent
Measured: From Baseline to month 6 and to month12
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 month12
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 month12
Change of average brush time
The average time used for tooth brushing presented in min and sec.
Measured: From Baseline to month 6 and to month12
Change in the number of brush sessions
The number of uses of the toothbrush per day
Measured: From Baseline to month 6 and to month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jun 2018
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
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 GingivitisStudies 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
- 213 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
- NCT05941611
- Sponsor's protocol ID
- BTH-6.1.1-0084-2023
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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, Larsson T, Sanmartin-Berglund J. Results of objective brushing data recorded from a powered toothbrush used by elderly individuals with mild cognitive impairment related to values for oral health. Clin Oral Investig. 2023 Dec 21;28(1):8. doi: 10.1007/s00784-023-05407-2.
PubMed 38123762
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Objective Brushing Data Recorded From a Powered Toothbrush Used by Elderly Individuals With Mild Cognitive Impairment Related to Values for Oral Health
- ClinicalTrials.gov ID
- NCT05941611
- Acronym / sponsor ID
- BTH-6.1.1-0084-2023
- Conditions
- Gingivitis, Periodontal Diseases
- Keywords
- Mild Cognitive Impairment, Oral Health, Powered toothbrush
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Blekinge Institute of TechnologyUniversity, hospital or other
- Collaborators
- Kristianstad University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 12 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 were recruited. During the Baseline examination, each participant received a powered toothbrush and was carefully instructed on how to use the toothbrush and recommended using it for at least 2 minutes every morning and evening. No restrictions were imposed on the use of other oral health products. The study lasted from June 2018 to October 2020 and included a screening, a baseline examination, and additional reexaminations at 6 and 12 months. The Oral-B application was installed on the participant's mobile phones or computer tablets. Participants were instructed verbally and in writing on transferring data from the powered toothbrush to the application. The present study aimed to investigate how the true use of the powered toothbrush, in terms of frequency and duration, affects plaque index (PI), bleeding on probing (BOP), and periodontal pocket depth (PPD) ≥4 mm in a group of elderly individuals with MCI. A second aim was to compare the registered time and brush frequencies to the individual's self-estimated usage of the powered toothbrushes.
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 month12
Plaque Index in percent
Change in the amount of gingival bleeding on probing
Time frame: From Baseline to month 6 and to month12
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 month12
The number of periodontal pockets 4 mm or deeper measured on four of the tooth surfaces presented as a percentage
Change of average brush time
Time frame: From Baseline to month 6 and to month12
The average time used for tooth brushing presented in min and sec.
Change in the number of brush sessions
Time frame: From Baseline to month 6 and to month12
The number of uses of the toothbrush per day
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 12 Jul 2023.
- Derived from this study: PubMed 38123762Flyborg J, Renvert S, Anderberg P, Larsson T, Sanmartin-Berglund J. Results of objective brushing data recorded from a powered toothbrush used by elderly individuals with mild cognitive impairment related to values for oral health. Clin Oral Investig. 2023 Dec 21;28(1):8. doi: 10.1007/s00784-023-05407-2.
- Individual participant dataSharing planned: Yes. 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
1 site 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 Gingivitis and Periodontal Diseases, run by Blekinge Institute of Technology at 1 site 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 12 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 1 site 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 month12). 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 NCT05941611, 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 12 Jul 2023.