Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene

January 8, 2024 updated by: University Ghent

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:

  • 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

    o Standard treatment: Evaluation of oral hygiene Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth

    o Study-specific treatment (duration: 10 minutes): Clinical photographs

  • Consultation 2 - after 3 weeks:

    o Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index

    o Study-specific treatment (duration: 10 minutes): Clinical photographs

  • Consultation 3 - after 6 weeks:

    o 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:

    o 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:

    o Standard treatment: Evaluation of oral hygiene and brushing frequency. Determination of clinical score: plaque score, gingival bleeding index Determination of pocket depth

    o 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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Geraardsbergen, Oost-Vlaanderen, Belgium, 9570
      • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • Recruiting
        • Praktijk voor Parodontologie
        • Contact:
      • Zottegem, Oost-Vlaanderen, Belgium, 9620
        • Recruiting
        • Centrum voor Parodontologie en Orale Implantologie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Smoking
  • Systemic disease
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator: Control group: Manual Toothbrush
Patients will receive oral hygiene instructions and a new manual toothbrush
Behavioral: Oral hygiene instructions
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.
Experimental: Test group: Electric Toothbrush without visual feedback
Patients will receive the same oral hygiene instructions and an electric toothbrush without daily personal feedback using the brushing application.
Behavioral: Oral hygiene instructions
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.
Device: Electric toothbrush
Patients will receive oral hygiene instructions and an electric toothbrush with or without daily personal feedback using the brushing app (Oral-B app).
Experimental: Test group: Electric Toothbrush with visual feedback
Patients will receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app).
Behavioral: Oral hygiene instructions
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.
Device: Electric toothbrush
Patients will receive oral hygiene instructions and an electric toothbrush with or without daily personal feedback using the brushing app (Oral-B app).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral hygiene with or without visual feedback
Time Frame: 12 weeks
Comparing the plaque scores at intake with those at final check-up
12 weeks
Oral hygiene with or without visual feedback
Time Frame: 12 weeks
Comparing the gingival bleeding index at intake with those at final check-up
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioural changes
Time Frame: 12 weeks
Brushing frequency will be evaluated using the brushing diary (minutes)
12 weeks
Behavioural changes
Time Frame: 12 weeks
Brushing durations will be evaluated using the brushing diary (number of times)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Véronique Christiaens, Prof. Dr., University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-11037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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