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Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene

Primary Purpose

Toothbrushing, Oral Hygiene, Dental Plaque

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Electric toothbrush
Oral hygiene instructions
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toothbrushing focused on measuring Dental plaque, Toothbrush, Oscillating-rotating, Manual, Electric, Dental Plaque Index, Electrical Equipment and Supplies

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BV Paro GlibertRecruiting
  • Ghent UniversityRecruiting
  • Praktijk voor ParodontologieRecruiting
  • Centrum voor Parodontologie en Orale ImplantologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Active Comparator: Control group: Manual Toothbrush

Test group: Electric Toothbrush without visual feedback

Test group: Electric Toothbrush with visual feedback

Arm Description

Patients will receive oral hygiene instructions and a new manual toothbrush

Patients will receive the same oral hygiene instructions and an electric toothbrush without daily personal feedback using the brushing application.

Patients will receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app).

Outcomes

Primary Outcome Measures

Oral hygiene with or without visual feedback
Comparing the plaque scores at intake with those at final check-up
Oral hygiene with or without visual feedback
Comparing the gingival bleeding index at intake with those at final check-up

Secondary Outcome Measures

Behavioural changes
Brushing frequency will be evaluated using the brushing diary (minutes)
Behavioural changes
Brushing durations will be evaluated using the brushing diary (number of times)

Full Information

First Posted
January 30, 2023
Last Updated
February 9, 2023
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05723133
Brief Title
Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene
Official Title
A Randomized Controlled Trial Comparing Manual Versus Powered Toothbrushes With Visual Feedback
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toothbrushing, Oral Hygiene, Dental Plaque
Keywords
Dental plaque, Toothbrush, Oscillating-rotating, Manual, Electric, Dental Plaque Index, Electrical Equipment and Supplies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The patient and treating dentist cannot be masked. The investigators and outcome assessors are masked
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Control group: Manual Toothbrush
Arm Type
Active Comparator
Arm Description
Patients will receive oral hygiene instructions and a new manual toothbrush
Arm Title
Test group: Electric Toothbrush without visual feedback
Arm Type
Experimental
Arm Description
Patients will receive the same oral hygiene instructions and an electric toothbrush without daily personal feedback using the brushing application.
Arm Title
Test group: Electric Toothbrush with visual feedback
Arm Type
Experimental
Arm Description
Patients will receive the same oral hygiene instructions and an electric toothbrush with daily personal feedback using the brushing app (Oral-B app).
Intervention Type
Device
Intervention Name(s)
Electric toothbrush
Intervention Description
Patients will receive oral hygiene instructions and an electric toothbrush with or without daily personal feedback using the brushing app (Oral-B app).
Intervention Type
Behavioral
Intervention Name(s)
Oral hygiene instructions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral hygiene with or without visual feedback
Description
Comparing the plaque scores at intake with those at final check-up
Time Frame
12 weeks
Title
Oral hygiene with or without visual feedback
Description
Comparing the gingival bleeding index at intake with those at final check-up
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Behavioural changes
Description
Brushing frequency will be evaluated using the brushing diary (minutes)
Time Frame
12 weeks
Title
Behavioural changes
Description
Brushing durations will be evaluated using the brushing diary (number of times)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Christiaens, Prof. Dr.
Phone
093324017
Email
vchristi.christiaens@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Maarten Glibert, Dr.
Phone
055890680
Email
maarten.glibert@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Christiaens, Prof. Dr.
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
BV Paro Glibert
City
Geraardsbergen
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9570
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten Glibert, Dr.
Phone
055890680
Email
maarten.glibert@ugent.be
Facility Name
Ghent University
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Cosyn, Professor
Email
jan.cosyn@ugent.be
Facility Name
Praktijk voor Parodontologie
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Lamoral
Phone
037770197
Email
sabine.lamoral@ugent.be
Facility Name
Centrum voor Parodontologie en Orale Implantologie
City
Zottegem
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9620
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Cosyn, Professor
Phone
0496100121
Email
jan.cosyn@ugent.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32243576
Citation
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.
Results Reference
result
PubMed Identifier
23448083
Citation
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.
Results Reference
result
PubMed Identifier
32243573
Citation
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.
Results Reference
result

Learn more about this trial

Visual Feedback on Brushing Technique and Habits on Patient Oral Hygiene

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