Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2024-07-02
2024-12-31
Brief Summary
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* 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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Buccocéan
Mouthwash, twice a day
Buccocéan mouthwash
Normal conditions of use
Marketed mouthwash
Mouthwash, twice a day
Marketed mouthwash
Normal conditions of use
Interventions
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Buccocéan mouthwash
Normal conditions of use
Marketed mouthwash
Normal conditions of use
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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YSLab
INDUSTRY
Responsible Party
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Locations
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Dentistry center
Rennes, , France
Countries
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Other Identifiers
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BUCCOCEAN
Identifier Type: -
Identifier Source: org_study_id
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