Evaluation of the Effect of the Toothpaste on Delicate Gums (NCT07494747) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Effect of the Toothpaste on Delicate Gums
Spain60 participantsStarted 2026-03-24
Plain-language summary
The goal of this study is to learn if a toothpaste 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 toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis.
Participants will:
* Use assigned toothpaste 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:
. 40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
. 60% of them with generalized gingivitis (\>30% of evaluated sites with bleeding) Repartition to be respected in both study groups.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 the Gingival Index at 1 month
Timeframe: From baseline to end of treatment at 1 month
. 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
. 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)