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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:
Participants will be asked to use the investigated mouthwash or the comparative mouthwash twice a day for 21 days.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccocéan | Experimental | Mouthwash, twice a day |
|
| Marketed mouthwash | Active Comparator | Mouthwash, twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buccocéan mouthwash | Other | Normal conditions of use |
| |
| Marketed mouthwash |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dentistry center | Rennes | France |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Other |
Normal conditions of use |
|
| 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 |
| D009057 |
| Stomatognathic Diseases |