Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

NCT07575997 | Recruiting

• 1 other identifier: PR52952025001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontal Disease

Keywords

Periodontal Disease; Interdental Brushes

Outcome Measures

Primary Outcomes (6)

• Effect on dental plaque

  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

  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

  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

  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

  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

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

  Visit 2 (Day 29)

Study Arms (2)

Test interdental brush

OTHER

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

Other: Test interdental brush

Comparative interdental brush

OTHER

Each subject uses the comparative interdental brush on the contralateral side of the mouth for 4 weeks.

Other: Comparative interdental brush

Interventions

Test interdental brush OTHER

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

Test interdental brush

Comparative interdental brush OTHER

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

Comparative interdental brush

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))
• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Selena TOMA, Pr.

  UC Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline BACQUEY

CONTACT

0534506533; adeline.bacquey@pierre-fabre.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-individual split-mouth randomized comparative study in adults with periodontal disease. Subjects enrolled in the study will use the test interdental brush on one side of the mouth and comparative interdental brush on contralateral side of the mouth for 4 weeks.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

BE (1)