Comparing two interdental brush types for adults with periodontal disease

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

This will test whether one interdental brush works better than another for adults with periodontal disease over a four-week period.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Pierre Fabre Dermo Cosmetique (industry)
• Locations: 1 site (Brussels)
• Trial ID: NCT07575997 on ClinicalTrials.gov

What this trial studies

This single-center, randomized, intra-individual split-mouth study compares a tested interdental brush with a comparative interdental brush in adults with active generalized periodontal disease over four weeks. Each participant uses one brush type on one side of the mouth and the other brush on the opposite side, with random assignment at the inclusion visit. Three visits are scheduled: pre-inclusion screening, inclusion/randomization and start of use, and an end-of-study visit about one month later. Outcomes focus on interdental cleaning efficacy measured at baseline and at the end of the study.

Who should consider this trial

Good fit: Adults aged 18 to 80 with active generalized periodontal disease who have at least 20 natural teeth, can give informed consent, and can attend three clinic visits are eligible.

Not a fit: People with only gingivitis, fewer than 20 natural teeth, other oral conditions or orthodontic appliances that interfere with assessment, pregnant or breastfeeding women, or those unable to consent are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, the results could identify a better interdental brush to improve interdental cleaning and reduce gum inflammation for people with periodontal disease.

How similar studies have performed: Prior research shows interdental brushes generally reduce plaque and gum bleeding compared with floss or no interdental cleaning, but direct head-to-head comparisons of specific brush designs are limited.

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

Where this trial is running

Brussels

• Cliniques universitaires Saint-Luc — Brussels, Belgium (RECRUITING)

Study contacts

• Principal investigator: Selena TOMA, Pr. — UC Louvain
• Study coordinator: Adeline BACQUEY

Conditions: Periodontal Disease, Interdental Brushes