Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

May 4, 2026 updated by: Pierre Fabre Dermo Cosmetique

A Clinical Study Evaluating the Efficacy of an Interdental Brush Versus Comparators in Adults With Periodontal Disease.

The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will take place at a single center as an intra-individual, split mouth, randomized, comparative study to evaluate the efficacy of the tested interdental brushes versus the comparative interdental brushes in adults with periodontal disease, over a 4-week period.

3 visits are planned:

  • Visit 0: Pre-inclusion (Day -21 to Day 1): Information of the study given to subject, checking eligibility criteria orally
  • Visit 1: Inclusion visit (Day 1): Randomization and Start of interdental brushes use (tested and comparative on each split-mouth)
  • Visit 2: End of study (Day 29 +/-7 days , i.e. 1 month after inclusion)

Study Type

Interventional

Enrollment (Estimated)

88

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 Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-luc
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject aged between 18 and 80 years included
  • Subject having signed his/her written informed consent for his/her participation in the study
  • Subject diagnosed with active generalized periodontal disease (excluding gingivitis)
  • Subject having at least 20 natural teeth (10 teeth on each side (right and left))

Non-inclusion criteria:

  • Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in a questionnaire
  • For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
  • Subject having any other oral condition than periodontal disease (ex: dermatologic ulcers), or any orthodontic conditions liable to interfere with the study assessment or considered by the investigator hazardous for the subject or incompatible with study requirements
  • Systemic treatment or topical treatment/product currently taken/applied in the mouth liable to interfere with study assessments according to the investigator or planned to be taken/applied during the study
  • Subject has received periodontal therapy (scaling, root planing, surgery, etc.) within 2 months before the inclusion
  • Subject who has undergone oral or gum surgery within 2 months before the inclusion, or planned to be performed during the study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Test interdental brush
Each subject uses the test interdental brush on one side of the mouth for 4 weeks.
Other: Test interdental brush
Interdental brush to be used twice a day during the whole study.
Other: Comparative interdental brush
Each subject uses the comparative interdental brush on the contralateral side of the mouth for 4 weeks.
Other: Comparative interdental brush
Interdental brush to be used twice a day during the whole study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on dental plaque
Time Frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth.
Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Effect on gingival bleeding
Time Frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Gingival bleeding (%) will be assessed on each side of the mouth.
Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Effect on pocket depth
Time Frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Pocket depth (mm) will be assessed on each side of the mouth.
Change from Visit 1 (Day 1) to Visit 2 (Day 29).
Interdental hygiene assessment by subject
Time Frame: Visit 2 (Day 29).
Interdental hygiene on each side of the mouth at Visit 2 compared to Visit 1 will be assessed by the subject using a 4-point scale (0: no change, -1: slightly improvement, 2: improvement, 3: significant improvement)
Visit 2 (Day 29).
Adverse events recording
Time Frame: From Visit 1 (Day 1) to Visit 2 (Day 29)
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
From Visit 1 (Day 1) to Visit 2 (Day 29)
Acceptability Questionnaire assessment
Time Frame: Visit 2 (Day 29)
Acceptability questionnaire regarding the use of the interdental brushes will be completed by the subject.
Visit 2 (Day 29)

Collaborators and Investigators

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

Sponsor

Pierre Fabre Dermo Cosmetique

Investigators

  • Principal Investigator: Selena TOMA, Pr., UC Louvain

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)

April 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR52952025001

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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