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RecruitingNCT07575997Updated May 8, 2026

Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

An interventional study of Test interdental brush and Comparative interdental brush in Periodontal Disease, sponsored by Pierre Fabre Dermo Cosmetique. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Pierre Fabre Dermo Cosmetique · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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)
02

Conditions studied

  • Periodontal Disease

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Keywords

  • Periodontal Disease
  • Interdental Brushes
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Other
    Test interdental brush

    Each subject uses the test interdental brush on one side of the mouth for 4 weeks.

    Other: Test interdental brush

  • 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

Interventions

  • OtherTest interdental brush

    Interdental brush to be used twice a day during the whole study.

  • OtherComparative interdental brush

    Interdental brush to be used twice a day during the whole study.

05

What researchers measure

Primary outcomes

  1. Effect on dental plaque

    Dental plaque (%) will be assessed according to the O'Leary method on each side of the mouth.

    Time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).

  2. Effect on gingival bleeding

    Gingival bleeding (%) will be assessed on each side of the mouth.

    Time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).

  3. Effect on pocket depth

    Pocket depth (mm) will be assessed on each side of the mouth.

    Time frame: Change from Visit 1 (Day 1) to Visit 2 (Day 29).

  4. Interdental hygiene assessment by subject

    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)

    Time frame: Visit 2 (Day 29).

  5. Adverse events recording

    Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation

    Time frame: From Visit 1 (Day 1) to Visit 2 (Day 29)

  6. Acceptability Questionnaire assessment

    Acceptability questionnaire regarding the use of the interdental brushes will be completed by the subject.

    Time frame: Visit 2 (Day 29)

06

Study locations

1 of 1 sites recruiting
  • Cliniques universitaires Saint-Luc
    Brussels, 1200, Belgium
    Recruiting
07

Registry details

Key details

Study ID
NCT07575997
Lead sponsor
Pierre Fabre Dermo Cosmetique
Responsible party
Sponsor
First posted
May 8, 2026
Start date
Apr 10, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
May 8, 2026

Study contacts

Adeline BACQUEY
Contact
adeline.bacquey@pierre-fabre.com
0534506533
Selena TOMA, Pr.
principal investigator · UC Louvain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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