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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Véronique Christiaens, Prof. Dr. contact

093324017

vchristi.christiaens@ugent.be

Maarten Glibert, Dr. contact

055890680

maarten.glibert@ugent.be

Belgium4 sites, 4 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

    Recruiting

Other trials in Belgium

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
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 groups in NCT05723133
Study groupRoleWhat they receive
Active Comparator: Control group: Manual ToothbrushActive comparatorPatients will receive oral hygiene instructions and a new manual toothbrush
Receives: Behavioral: Oral hygiene instructions
Test group: Electric Toothbrush without visual feedbackExperimentalPatients 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 feedbackExperimentalPatients 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.

  1. Oral hygiene with or without visual feedback

    Comparing the plaque scores at intake with those at final check-up

    Measured: 12 weeks

  2. 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)
  1. Behavioural changes

    Brushing frequency will be evaluated using the brushing diary (minutes)

    Measured: 12 weeks

  2. 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.

  1. First posted10 Feb 2023
  2. Study start24 Feb 2022
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Jul 2024 (estimated)

Resources

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)
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 32243576
  • Nathoo 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 23448083
  • Grender 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

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.

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