Comparing two interdental brush types for adults with periodontal disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cliniques universitaires Saint-Luc
  Brussels, Belgium Recruiting

Study contacts

• Principal investigator: Selena TOMA, Pr. — UC Louvain
• Study coordinator: Adeline BACQUEY
• Email: adeline.bacquey@pierre-fabre.com
• Phone: 0534506533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.