Usage Test on a New Cosmetic Product: Mouthwash

NCT06808711 | Completed

• 1 other identifier: BUCCOCEAN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sensitive Gum; Gum Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Soothing effect on irritated gums

  At Day 0 and Day 7

• Effect on dental plaque

  At Day 0 and Day 7

• Effect on the oral microbiota

  At Day 0 and Day 7

Study Arms (2)

Buccocéan

EXPERIMENTAL

Mouthwash, twice a day

Other: Buccocéan mouthwash

Marketed mouthwash

ACTIVE COMPARATOR

Mouthwash, twice a day

Other: Marketed mouthwash

Interventions

Buccocéan mouthwash OTHER

Normal conditions of use

Buccocéan

Marketed mouthwash OTHER

Normal conditions of use

Marketed mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person (man, woman) aged 18 or over,
• Person capable of following the instructions for using the product,
• Volunteer informed and having signed their informed consent form,
• Volunteer person affiliated to a social security scheme (Art L1121-11 of the CSP).

You may not qualify if:

• Person who has regularly used mouthwash in the last month,
• Person suffering from periodontitis
• 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).

Sponsors & Collaborators

• YSLab: lead

Study Sites (1)

Dentistry center

Rennes, France

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 5, 2025
• Study Start: July 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-01

Locations

FR (1)