NCT07575997RecruitingNot Applicable
A Clinical Study Evaluating the Efficacy of an Interdental Brush Versus Comparators in Adults With Periodontal Disease.
Pierre Fabre Dermo Cosmetique1 site in 1 country88 target enrollmentStarted: April 10, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 1
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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