Evaluation of the Effect of the Mouthwash on Delicate Gums (NCT07551908) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Effect of the Mouthwash on Delicate Gums
30 participantsStarted 2026-04-03
Plain-language summary
The goal of this study is to learn if a mouthwash works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is:
• Does the mouthwash help to improve signs of gingivitis?
Participants will:
* Use mouthwash daily for 4 weeks
* Visit the clinic on the established days during 4 weeks for check-ups and evaluation
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male and female subjects (with no specific repartition)
. Subjects of Caucasian ethnicity
. Subjects aged between 18 and 65 years (extremes included)
. Subjects clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and 2.3, according to Löe and Silness gingival scoring system), in particular:
. 20% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
. 80% of them with generalized gingivitis (\>30% of evaluated sites with bleeding)
. Subjects with dental plaque (total plaque score at inclusion ≥2)
. Subjects registered with the national health service
Exclusion criteria
. Subjects who do not meet the inclusion criteria
. Smokers subjects
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a mouthwash for sensitive or delicate gums and it hasn't started recruiting yet — given that timeline uncertainty, is there a standard gingivitis treatment I should start now rather than waiting to see if I can participate?
2The trial measures changes in a Gingival Index Score over 4 weeks, which sounds fairly short — is 4 weeks enough time to know whether a mouthwash is actually helping my gum inflammation, and what would happen to my care after those 4 weeks end?
3Since this is listed as 'Phase NA,' which often means it's more of a consumer product evaluation than a traditional drug trial, how does that affect what we'd learn about safety and effectiveness compared to a standard clinical drug study?
4The trial focuses specifically on people with delicate or sensitive gums — based on my current gum health, do you think I'd even be a good candidate for this kind of study, and are there risks of worsening my gingivitis if the mouthwash doesn't work well for me?
5Are there already proven mouthwash treatments or professional cleaning routines you'd recommend for my gingivitis that I could pursue now, and how would those compare to what this trial might offer?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Gingival Index Score at 4 weeks
Timeframe: From enrolment to the end of use at 4 weeks.
. Subjects planning toothcare during the study period
. Subjects using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of periodontitis (periodontal probing depth \>3mm) or active periodontitis
. Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study
. Subjects participating or planning to participate in other clinical trials
. Subjects who participated in a similar study without respecting an adequate washout period (at least one month)