ToothbrushingNCT05723133
Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene
A study testing Electric toothbrush and Oral hygiene instructions in people with Toothbrushing and Oral Hygiene, run by University Ghent at 4 sites in Belgium.
Trial summary
The goal of this clinical trial is to learn about the influence of providing visual feedback on brushing technique and habits on oral health of patients undergoing periodontal treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Toothbrushing, Oral Hygiene, Dental Plaque
- What is being tested?
- Electric toothbrush and Oral hygiene instructions
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesBelgium
- Study dates
- 24 Feb 2022to 30 Jul 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in need of periodontal treatment
- Willing to keep a brushing diary
- Possess a smartphone so that they are able to install and handle the application on their phone
Who cannot join
- Smoking
- Systemic disease
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites, 4 recruiting
- Recruiting
BV Paro Glibert
Geraardsbergen, Oost-Vlaanderen, 9570
Maarten Glibert, Dr., 055890680, maarten.glibert@ugent.be
- Recruiting
Ghent University
Ghent, Oost-Vlaanderen, 9000
Jan Cosyn, Professor, jan.cosyn@ugent.be
- Recruiting
Praktijk voor Parodontologie
Sint-Niklaas, Oost-Vlaanderen, 9100
Sabine Lamoral, 037770197, sabine.lamoral@ugent.be
- Recruiting
Centrum voor Parodontologie en Orale Implantologie
Zottegem, Oost-Vlaanderen, 9620
Jan Cosyn, Professor, 0496100121, jan.cosyn@ugent.be
About this study
Official title: A Randomized Controlled Trial Comparing Manual Versus Powered Toothbrushes With Visual Feedback
The goal of this clinical trial is to learn about the influence of providing visual feedback on brushing technique and habits on oral health of patients undergoing periodontal treatment.
The main question[s] it aims to answer are:
Read more
- Is patients' oral health improved by providing visual feedback on their brushing technique using the smartphone brushing app?
- Is there behavioural change of patients based on this daily visual feedback? Participants will receive oral hygiene instructions after initial periodontal treatment and will be randomized in group 1, 2 or 3. Participants will be asked to
- fulfill a brushing diary with the time of brushing every day.
- come back for a check-up appointment every 3 weeks during the study to evaluate oral hygiene.
Researchers will compare manual toothbrush, electric toothbrush without daily personal feedback and electric toothbrush with daily personal feedback to see if visual feedback provide improved oral health
Read the detailed description
Periodontitis is gum disease with jawbone deterioration. Diagnosis is based on clinical examination: plaque score, pocket measurement (measuring the pockets or gum pockets around the teeth with a probe), gingival bleeding index (= bleeding after probing) and radiographic examination. Smoking, genetic factors, and systemic diseases such as diabetes, for example, are known risk factors for this condition. Treatment consists of a deep cleaning, where the tooth roots are freed of plaque and tartar under local anaesthesia, complemented by the necessary oral hygiene instructions. It is important that patients follow these oral hygiene instructions carefully at home and perform them daily, as the aim is to achieve optimal oral hygiene. Good oral hygiene is fundamental in the treatment of periodontitis (Arweiler et al, 2018).
Despite many patients undergoing the proposed professional treatment (deep cleaning), they are often insufficiently able to remove the dental plaque present on a daily basis. To optimise brushing efficiency, both behavioural change and improved brushing technique should be obtained at the patient level.
The primary aim of this randomised clinical trial is to improve patients' oral health by providing visual feedback on their brushing technique using the smartphone brushing app. The secondary aim of the study is to investigate possible behavioural changes of patients based on this daily visual feedback.
Patients requiring periodontal treatment will be recruited at the Department of Periodontology \& Oral Implantology at Ghent University Hospital. Patients will be assigned to three groups by randomisation. In group 1, patients will receive oral hygiene instructions and a new manual toothbrush. In group 2, patients receive the same oral hygiene instructions and a basic electric toothbrush without daily personal feedback using the brushing application. In group 3, patients receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app). No raw study data will be transferred to Oral B. The only data that will be available to Oral-B is the data that will be included in the publication of this study (A1 article). The use of the app does not require registration of personal data. Brushing time, tooth surface cleaning and brushing pressure will be recorded. Patients will only complete the brushing time in the brushing diary.
Oral hygiene will be evaluated at the start and every 3 weeks during the study through a check-up appointment. Only the first (after 3 weeks) and the last check-up appointment (after 12 weeks) are standard protocol, the remaining appointments (after 6 and 9 weeks) are study-specific. Oral hygiene will be assessed by: plaque score, gingival bleeding index, brushing frequency and brushing duration. The full study will take 12 weeks. Pocket depth will be measured according to usual protocols, namely at intake and at the last check-up (after 12 weeks). The patient's brushing technique and frequency will be recorded through a brushing diary completed by the patient. Where necessary, oral hygiene can be adjusted during each sitting. The check-up after 3 weeks and 12 weeks with measurement of plaque scores, gingival bleeding index and pocket depth are part of the standard protocol for treating periodontitis and are therefore not study-specific. Monitoring after 6 and 9 weeks are study-specific. The primary goal will be evaluated by comparing plaque scores and gingival bleeding index at intake with those at the final check. The secondary goal will be evaluated by brushing frequency and brushing duration throughout the study course. All data collected will be pseudonymised.
Overview:
- Consultation 1 - at start:
- Standard treatment: Evaluation of oral hygiene Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth
- Study-specific treatment (duration: 10 minutes): Clinical photographs
- Consultation 2 - after 3 weeks:
- Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index
- Study-specific treatment (duration: 10 minutes): Clinical photographs
- Consultation 3 - after 6 weeks:
- Study-specific treatment (duration: 30 minutes ): Evaluation of oral hygiene + clinical photographs Determination of clinical score: plaque score, gingival bleeding index
- Consultation 4 - after 9 weeks:
- Study-specific treatment (duration: 30 minutes ): Evaluation of oral hygiene + clinical photographs Determination of clinical score: plaque score, gingival bleeding index
- Consultation 5 - after 12 weeks:
- Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth
- Study-specific treatment (duration: 10 minutes): Clinical photographs
- Completion of the brushing diary by the patient:
- Brushing time, cleaning of tooth surfaces, brushing pressure, brushing technique, frequency and motivation
- 2x a day, 2 min per brushing
- Conditions
- Toothbrushing, Oral Hygiene, Dental Plaque
- Being tested
- Electric toothbrush, Oral hygiene instructions
- Keywords
- Dental plaque, Toothbrush, Oscillating-rotating, Manual, Electric, Dental Plaque Index, Electrical Equipment and Supplies
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric toothbrushDevice
Patients will receive oral hygiene instructions and an electric toothbrush with or without daily personal feedback using the brushing app (Oral-B app).
Oral hygiene instructionsBehavioural
The same oral hygiene instructions are given to all patients. It is important for the patient to scrupulously follow these oral hygiene instructions at home and carry them out daily.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Control group: Manual Toothbrush | Active comparator | Patients will receive oral hygiene instructions and a new manual toothbrush Receives: Behavioral: Oral hygiene instructions |
| Test group: Electric Toothbrush without visual feedback | Experimental | Patients will receive the same oral hygiene instructions and an electric toothbrush without daily personal feedback using the brushing application. Receives: Device: Electric toothbrush; Behavioral: Oral hygiene instructions |
| Test group: Electric Toothbrush with visual feedback | Experimental | Patients will receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app). Receives: Device: Electric toothbrush; Behavioral: Oral hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene with or without visual feedback
Comparing the plaque scores at intake with those at final check-up
Measured: 12 weeks
Oral hygiene with or without visual feedback
Comparing the gingival bleeding index at intake with those at final check-up
Measured: 12 weeks
Secondary outcomes (2)
Behavioural changes
Brushing frequency will be evaluated using the brushing diary (minutes)
Measured: 12 weeks
Behavioural changes
Brushing durations will be evaluated using the brushing diary (number of times)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start24 Feb 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ToothbrushingStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with 3 treatment arms (control group: manual toothbrush; test group 1: electric toothbrush without digital visual feedback; test group 2: electric toothbrush with visual feedback). Every patient received the same initial treatment and oral hygiene instructions. Sealed envelops will determine in which group the patient will participate.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Christiaens, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723133
- Sponsor's protocol ID
- BC-11037
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adam R, Ram Goyal C, Qaqish J, Grender J. Evaluation of an oscillating-rotating toothbrush with micro-vibrations versus a sonic toothbrush for the reduction of plaque and gingivitis: results from a randomized controlled trial. Int Dent J. 2020 Apr;70 Suppl 1(Suppl 1):S16-S21. doi: 10.1111/idj.12569.
PubMed 32243576Nathoo S, Mankodi S, Mateo LR, Chaknis P, Panagakos F. A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush. J Clin Dent. 2012;23 Spec No A:A11-6.
PubMed 23448083Grender J, Ram Goyal C, Qaqish J, Adam R. An 8-week randomized controlled trial comparing the effect of a novel oscillating-rotating toothbrush versus a manual toothbrush on plaque and gingivitis. Int Dent J. 2020 Apr;70 Suppl 1(Suppl 1):S7-S15. doi: 10.1111/idj.12571.
PubMed 32243573
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Manual Versus Powered Toothbrushes With Visual Feedback
- ClinicalTrials.gov ID
- NCT05723133
- Acronym / sponsor ID
- BC-11037
- Conditions
- Toothbrushing, Oral Hygiene, Dental Plaque
- Keywords
- Dental plaque, Toothbrush, Oscillating-rotating, Manual, Electric, Dental Plaque Index, Electrical Equipment and Supplies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 10 Feb 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.
The goal of this clinical trial is to learn about the influence of providing visual feedback on brushing technique and habits on oral health of patients undergoing periodontal treatment.
The main question[s] it aims to answer are:
- Is patients' oral health improved by providing visual feedback on their brushing technique using the smartphone brushing app?
- Is there behavioural change of patients based on this daily visual feedback? Participants will receive oral hygiene instructions after initial periodontal treatment and will be randomized in group 1, 2 or 3. Participants will be asked to
- fulfill a brushing diary with the time of brushing every day.
- come back for a check-up appointment every 3 weeks during the study to evaluate oral hygiene.
Researchers will compare manual toothbrush, electric toothbrush without daily personal feedback and electric toothbrush with daily personal feedback to see if visual feedback provide improved oral health
Detailed description
Periodontitis is gum disease with jawbone deterioration. Diagnosis is based on clinical examination: plaque score, pocket measurement (measuring the pockets or gum pockets around the teeth with a probe), gingival bleeding index (= bleeding after probing) and radiographic examination. Smoking, genetic factors, and systemic diseases such as diabetes, for example, are known risk factors for this condition. Treatment consists of a deep cleaning, where the tooth roots are freed of plaque and tartar under local anaesthesia, complemented by the necessary oral hygiene instructions. It is important that patients follow these oral hygiene instructions carefully at home and perform them daily, as the aim is to achieve optimal oral hygiene. Good oral hygiene is fundamental in the treatment of periodontitis (Arweiler et al, 2018).
Despite many patients undergoing the proposed professional treatment (deep cleaning), they are often insufficiently able to remove the dental plaque present on a daily basis. To optimise brushing efficiency, both behavioural change and improved brushing technique should be obtained at the patient level.
The primary aim of this randomised clinical trial is to improve patients' oral health by providing visual feedback on their brushing technique using the smartphone brushing app. The secondary aim of the study is to investigate possible behavioural changes of patients based on this daily visual feedback.
Patients requiring periodontal treatment will be recruited at the Department of Periodontology \& Oral Implantology at Ghent University Hospital. Patients will be assigned to three groups by randomisation. In group 1, patients will receive oral hygiene instructions and a new manual toothbrush. In group 2, patients receive the same oral hygiene instructions and a basic electric toothbrush without daily personal feedback using the brushing application. In group 3, patients receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app). No raw study data will be transferred to Oral B. The only data that will be available to Oral-B is the data that will be included in the publication of this study (A1 article). The use of the app does not require registration of personal data. Brushing time, tooth surface cleaning and brushing pressure will be recorded. Patients will only complete the brushing time in the brushing diary.
Oral hygiene will be evaluated at the start and every 3 weeks during the study through a check-up appointment. Only the first (after 3 weeks) and the last check-up appointment (after 12 weeks) are standard protocol, the remaining appointments (after 6 and 9 weeks) are study-specific. Oral hygiene will be assessed by: plaque score, gingival bleeding index, brushing frequency and brushing duration. The full study will take 12 weeks. Pocket depth will be measured according to usual protocols, namely at intake and at the last check-up (after 12 weeks). The patient's brushing technique and frequency will be recorded through a brushing diary completed by the patient. Where necessary, oral hygiene can be adjusted during each sitting. The check-up after 3 weeks and 12 weeks with measurement of plaque scores, gingival bleeding index and pocket depth are part of the standard protocol for treating periodontitis and are therefore not study-specific. Monitoring after 6 and 9 weeks are study-specific. The primary goal will be evaluated by comparing plaque scores and gingival bleeding index at intake with those at the final check. The secondary goal will be evaluated by brushing frequency and brushing duration throughout the study course. All data collected will be pseudonymised.
Overview:
- Consultation 1 - at start:
- Standard treatment: Evaluation of oral hygiene Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth
- Study-specific treatment (duration: 10 minutes): Clinical photographs
- Consultation 2 - after 3 weeks:
- Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index
- Study-specific treatment (duration: 10 minutes): Clinical photographs
- Consultation 3 - after 6 weeks:
- Study-specific treatment (duration: 30 minutes ): Evaluation of oral hygiene + clinical photographs Determination of clinical score: plaque score, gingival bleeding index
- Consultation 4 - after 9 weeks:
- Study-specific treatment (duration: 30 minutes ): Evaluation of oral hygiene + clinical photographs Determination of clinical score: plaque score, gingival bleeding index
- Consultation 5 - after 12 weeks:
- Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth
- Study-specific treatment (duration: 10 minutes): Clinical photographs
- Completion of the brushing diary by the patient:
- Brushing time, cleaning of tooth surfaces, brushing pressure, brushing technique, frequency and motivation
- 2x a day, 2 min per brushing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial with 3 treatment arms (control group: manual toothbrush; test group 1: electric toothbrush without digital visual feedback; test group 2: electric toothbrush with visual feedback). Every patient received the same initial treatment and oral hygiene instructions. Sealed envelops will determine in which group the patient will participate.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Control group: Manual Toothbrush | Active comparator | Behavioral: Oral hygiene instructionsPatients will receive oral hygiene instructions and a new manual toothbrush |
| Test group: Electric Toothbrush without visual feedback | Experimental | Device: Electric toothbrush, Behavioral: Oral hygiene instructionsPatients will receive the same oral hygiene instructions and an electric toothbrush without daily personal feedback using the brushing application. |
| Test group: Electric Toothbrush with visual feedback | Experimental | Device: Electric toothbrush, Behavioral: Oral hygiene instructionsPatients will receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in need of periodontal treatment
- Willing to keep a brushing diary
- Possess a smartphone so that they are able to install and handle the application on their phone
Key exclusion criteria (3 listed)
- Smoking
- Systemic disease
- Pregnancy
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 |
|---|---|---|
| Electric toothbrushPatients will receive oral hygiene instructions and an electric toothbrush with or without daily personal feedback using the brushing app (Oral-B app). | Device | Test group: Electric Toothbrush with visual feedback, Test group: Electric Toothbrush without visual feedback |
| Oral hygiene instructionsThe same oral hygiene instructions are given to all patients. It is important for the patient to scrupulously follow these oral hygiene instructions at home and carry them out daily. | Behavioural | Active Comparator: Control group: Manual Toothbrush, Test group: Electric Toothbrush with visual feedback, Test group: Electric Toothbrush without visual feedback |
Primary outcome
Oral hygiene with or without visual feedback
Time frame: 12 weeks
Comparing the plaque scores at intake with those at final check-up
Oral hygiene with or without visual feedback
Time frame: 12 weeks
Comparing the gingival bleeding index at intake with those at final check-up
2 secondary outcomes
Behavioural changes
Time frame: 12 weeks
Behavioural changes
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Results publication: PubMed 32243576Adam R, Ram Goyal C, Qaqish J, Grender J. Evaluation of an oscillating-rotating toothbrush with micro-vibrations versus a sonic toothbrush for the reduction of plaque and gingivitis: results from a randomized controlled trial. Int Dent J. 2020 Apr;70 Suppl 1(Suppl 1):S16-S21. doi: 10.1111/idj.12569.
- Results publication: PubMed 23448083Nathoo S, Mankodi S, Mateo LR, Chaknis P, Panagakos F. A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush. J Clin Dent. 2012;23 Spec No A:A11-6.
- Results publication: PubMed 32243573Grender J, Ram Goyal C, Qaqish J, Adam R. An 8-week randomized controlled trial comparing the effect of a novel oscillating-rotating toothbrush versus a manual toothbrush on plaque and gingivitis. Int Dent J. 2020 Apr;70 Suppl 1(Suppl 1):S7-S15. doi: 10.1111/idj.12571.
- Individual participant dataSharing planned: No
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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.
Véronique Christiaens, Prof. Dr. principal investigator
University Ghent
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric toothbrush and Oral hygiene instructions in people with Toothbrushing and Oral Hygiene, run by University Ghent at 4 sites in Belgium.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Véronique Christiaens, Prof. Dr. (093324017, vchristi.christiaens@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral hygiene with or without visual feedback (time frame: 12 weeks). The study lists 2 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 NCT05723133, which also lists 3 linked publications.
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 9 Jan 2024.