NCT06808711

Usage Test on a New Cosmetic Product: Mouthwash

Evaluation of the Tolerance and Effectiveness of Buccocean Mouthwash Under Real-use Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: YSLab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a new mouthwash can help soothing oral mucosa in adult patients with sensitive gums. The main questions it aims to answer are: * Does the investigated mouthwash soothe red gum? * Has the mouthwash antibacterial activities? Researchers will compare with a marketed mouthwash to see if the observed effect is due to the formula or to the general rinsing effect of any mouthwash. Participants will be asked to use the investigated mouthwash or the comparative mouthwash twice a day for 21 days.

Detailed description

Severity of gingival inflammation is evaluated using the Loë \& Silness scale, which includes 4 scores (0=no inflammation, 3=Significant inflammation, redness, accentuated hypertrophy with spontaneous hemorrhagic tendency and ulceration) by the dentist, on Day 0 and on Day 7. Presence of dental plaque is evaluated using the Loë \& Silness scale, which includes 4 scores (0=no dental plaque, 3=Abundant plaque along the gingival margin; the spaces between the teeth are filled with plaque) by the dentist, on Day 0 and on Day 7. Changes in the gingival microbiota is evaluated through the analysis of bacteria on D0 and D7 by swab sampling on the occlusal and buccal surfaces at the gum line. Tolerance (adverse effects) will also be studied by recording any adverse effect.

Conditions

• Sensitive Gum
• Gum Inflammation

Interventions

Type	Name	Description
OTHER	Buccocéan mouthwash	Normal conditions of use
OTHER	Marketed mouthwash	Normal conditions of use

Timeline

• Start date: 2024-07-02
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

1 site across 1 country: France