NCT05723133

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2.4 years

First QC Date

January 30, 2023

Last Update Submit

January 8, 2024

Conditions

Keywords

Dental plaqueToothbrushOscillating-rotatingManualElectricDental Plaque IndexElectrical Equipment and Supplies

Outcome Measures

Primary Outcomes (2)

  • Oral hygiene with or without visual feedback

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

    12 weeks

  • Oral hygiene with or without visual feedback

    Comparing the gingival bleeding index at intake with those at final check-up

    12 weeks

Secondary Outcomes (2)

  • Behavioural changes

    12 weeks

  • Behavioural changes

    12 weeks

Study Arms (3)

Active Comparator: Control group: Manual Toothbrush

ACTIVE COMPARATOR

Patients will receive oral hygiene instructions and a new manual toothbrush

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.

Device: Electric toothbrushBehavioral: 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).

Device: Electric toothbrushBehavioral: Oral hygiene instructions

Interventions

Patients will receive oral hygiene instructions and an electric toothbrush with or without daily personal feedback using the brushing app (Oral-B app).

Test group: Electric Toothbrush with visual feedbackTest group: Electric Toothbrush without visual feedback

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.

Active Comparator: Control group: Manual ToothbrushTest group: Electric Toothbrush with visual feedbackTest group: Electric Toothbrush without visual feedback

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoking
  • Systemic disease
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

BV Paro Glibert

Geraardsbergen, Oost-Vlaanderen, 9570, Belgium

RECRUITING

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Praktijk voor Parodontologie

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

RECRUITING

Centrum voor Parodontologie en Orale Implantologie

Zottegem, Oost-Vlaanderen, 9620, Belgium

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Véronique Christiaens, Prof. Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Christiaens, Prof. Dr.

CONTACT

Maarten Glibert, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient and treating dentist cannot be masked. The investigators and outcome assessors are masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 10, 2023

Study Start

February 24, 2022

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations