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OpenTrials
Completed

NCT Number: NCT06808711

Usage Test on a New Cosmetic Product: Mouthwash

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dentistry center

Rennes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Buccocéan mouthwash

Other

Normal conditions of use

Marketed mouthwash

Other

Normal conditions of use

Primary outcomes

  1. Tolerance of the product

    Time frame: From enrollment to the end of treatment at 3 weeks

    Tolerance of the mouthwash expressed by the number of adverse effects linked to the product

Secondary outcomes

  1. Soothing effect on irritated gums

    Time frame: At Day 0 and Day 7

    Gingival index assessed by the dentist (Grade 0-3)

  2. Effect on dental plaque

    Time frame: At Day 0 and Day 7

    Plaque index by the dentist (grade 0-3)

  3. Effect on the oral microbiota

    Time frame: At Day 0 and Day 7

    Evaluation of the gingival microbiota by swab sampling on the occlusal and buccal surfaces at the gum line

Sponsors and collaborators

Lead sponsor

YSLab

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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