Dentistry center
Rennes, France
NCT Number: NCT06808711
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rennes, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Normal conditions of use
Normal conditions of use
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
Time frame: At Day 0 and Day 7
Gingival index assessed by the dentist (Grade 0-3)
Time frame: At Day 0 and Day 7
Plaque index by the dentist (grade 0-3)
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
YSLab
Industry
Evaluation of the Tolerance and Effectiveness of Buccocean Mouthwash Under Real-use Conditions
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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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