Evaluation of the Effect of the Toothpaste on Delicate Gums (NCT07494747) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Effect of the Toothpaste on Delicate Gums
Spain60 participantsStarted 2026-03
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 range18 Years – 65 Years
SexALL
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.
✓. 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
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 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)