Sensitive GumNCT06808711
Usage Test on a New Cosmetic Product: Mouthwash
A study testing Buccocéan mouthwash and Marketed mouthwash in people with Sensitive Gum and Gum Inflammation, run by YSLab at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensitive Gum, Gum Inflammation
- What is being tested?
- Buccocéan mouthwash and Marketed mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Buccocéan mouthwash, Marketed mouthwash
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccocéan mouthwashOther
Normal conditions of use
Marketed mouthwashOther
Normal conditions of use
| Study group | Role | What they receive |
|---|---|---|
| Buccocéan | Experimental | Mouthwash, twice a day Receives: Other: Buccocéan mouthwash |
| Marketed mouthwash | Active comparator | Mouthwash, twice a day Receives: Other: Marketed mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of the product
Tolerance of the mouthwash expressed by the number of adverse effects linked to the product
Measured: From enrollment to the end of treatment at 3 weeks
Secondary outcomes (3)
Soothing effect on irritated gums
Gingival index assessed by the dentist (Grade 0-3)
Measured: At Day 0 and Day 7
Effect on dental plaque
Plaque index by the dentist (grade 0-3)
Measured: 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
Measured: At Day 0 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start2 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive GumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- YSLab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808711
- Sponsor's protocol ID
- BUCCOCEAN
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Tolerance and Effectiveness of Buccocean Mouthwash Under Real-use Conditions
- ClinicalTrials.gov ID
- NCT06808711
- Acronym / sponsor ID
- BUCCOCEAN
- Conditions
- Sensitive Gum, Gum Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- YSLabIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccocéan | Experimental | Other: Buccocéan mouthwashMouthwash, twice a day |
| Marketed mouthwash | Active comparator | Other: Marketed mouthwashMouthwash, twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccocéan mouthwashNormal conditions of use | Other | Buccocéan |
| Marketed mouthwashNormal conditions of use | Other | Marketed mouthwash |
Primary outcome
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
3 secondary outcomes
Soothing effect on irritated gums
Time frame: At Day 0 and Day 7
Effect on dental plaque
Time frame: At Day 0 and Day 7
Effect on the oral microbiota
Time frame: At Day 0 and Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccocéan mouthwash and Marketed mouthwash in people with Sensitive Gum and Gum Inflammation, run by YSLab at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of the product (time frame: From enrollment to the end of treatment at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.