Usage Test on a New Cosmetic Product: Mouthwash

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

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.

Study Overview

• Status: Completed
• Conditions: Gum Inflammation; Sensitive Gum
• Intervention / Treatment: Other: Buccocéan mouthwash; Other: Marketed mouthwash

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • Dentistry center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Person (man, woman) aged 18 or over,
• Person with a gingival index ≥ 2 (according to Loë & Silness) on at least 10% of teeth (i.e. 3 teeth) at the inclusion visit
• Person capable of following the instructions for using the product,
• Person agreeing to come for a dental consultation 7 days (+/- 1 day) after the inclusion visit,
• Volunteer informed and having signed their informed consent form,
• Volunteer person affiliated to a social security scheme (Art L1121-11 of the CSP).

Exclusion Criteria:

• Person who has regularly used mouthwash in the last month,
• Person suffering from periodontitis
• Person having a scaling treatment planned in the session, or having had a scaling treatment in the 6 months preceding the inclusion visit,
• Person having had antibiotic or antifungal treatment in the 3 months preceding the visit,
• Person taking anti-coagulant or anti-aggregant or immunosuppressive or anti-cancer treatment (chemotherapy or radiotherapy of the head and neck)
• Person at risk of infective endocarditis,
• Person with a known sensitivity or allergy to one of the components of mouthwashes, including components derived from essential oils (Eucalyptol, thymol, menthol, limonene).
• Volunteer participating in intervention research.
• Vulnerable people referred to in articles L. 1121-5 to 8 and L. 1122-1-2 of the Public Health Code (institutionalized volunteers, deprived of their liberty or placed under legal protection (guardianship or curatorship).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Buccocéan; Mouthwash, twice a day	Other: Buccocéan mouthwash; Normal conditions of use
Active Comparator: Marketed mouthwash; Mouthwash, twice a day	Other: Marketed mouthwash; Normal conditions of use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of the product	Tolerance of the mouthwash expressed by the number of adverse effects linked to the product	From enrollment to the end of treatment at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soothing effect on irritated gums	Gingival index assessed by the dentist (Grade 0-3)	At Day 0 and Day 7
Effect on dental plaque	Plaque index by the dentist (grade 0-3)	At Day 0 and Day 7
Effect on the oral microbiota	Evaluation of the gingival microbiota by swab sampling on the occlusal and buccal surfaces at the gum line	At Day 0 and Day 7

Collaborators and Investigators

• Sponsor: YSLab

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: BUCCOCEAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No