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NCT Number: NCT07575997

Comparison Between Different Interdental Brushes 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.

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test interdental brush

Other

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

Comparative interdental brush

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. Acceptability Questionnaire assessment

    Time frame: Visit 2 (Day 29)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Adeline BACQUEY

CONTACT

[email protected]

0534506533

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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