toothpaste for gingivitis in adults
Official title: Benchmark Controlled Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition - in Use Test Under Dentist Control
Run by Lacer S.A. · NCT07494747 · Data updated 2026-11-12
A toothpaste is being tested in adults with gingivitis to see if it improves gum inflammation compared with a regular toothpaste.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Lacer S.A. Industry-sponsored |
| Locations | 1 site (Castelldefels, Barcelona) |
| Status | Recruiting |
| Started | March 24, 2026 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07494747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with moderate gingivitis and dental plaque, of Caucasian ethnicity, able to understand the study language, and registered with the national health service.
✕Probably not a fit
Individuals outside the age range, without signs of gingivitis, or not meeting plaque or bleeding criteria may not experience benefit from the toothpaste.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a gingivitis-targeted toothpaste to a regular toothpaste over four weeks. Adults with moderate gingival inflammation will use the assigned toothpaste daily and attend clinic visits for assessments. Primary questions are whether the gingivitis toothpaste improves gingival signs and whether it is safe. The study monitors dental plaque and bleeding as indicators of gingivitis severity. The lead sponsor is Lacer S.A., conducting at Clinica Ciurana Centre Dental in Castelldefels, Barcelona.
Why it matters
Potential benefit: If successful, participants may experience reduced gum inflammation and better oral health with the specialized toothpaste.
How similar studies have gone: Prior studies have explored targeted dentifrices for gingivitis; results vary, and this design aims to add evidence for a specific toothpaste product.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy male and female subjects (with no specific repartition) 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 65 years (extremes included) 4. 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: 1. 40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding) 2. 60% of them with generalized gingivitis (\>30% of evaluated sites with bleeding) Repartition to be respected in both study groups. 5. Subjects with dental plaque (total plaque score at inclusion ≥2) 6. Subjects registered with the national health service 7. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel 8. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel 9. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 10. Subjects who commit not to change their daily routine or lifestyle during the study 11. Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 12. Subjects informed about the test procedures who have signed a consent form and privacy agreement Exclusion Criteria: 1. Subjects who do not meet the inclusion criteria 2. Smokers subjects 3. Subjects planning toothcare during the study period 4. 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 5. Subjects using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period 6. 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 7. Subjects participating or planning to participate in other clinical trials 8. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 9. Subjects that have food intolerances or food allergies to ingredients of the study product 10. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator 11. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month) 12. Subjects admitted to a health or social facility 13. Subjects planning a hospitalization during the study 14. Subjects not able to be contacted in case of emergency 15. Subjects deprived of freedom by administrative or legal decision or under guardianship 16. Subjects who have or have had a history of alcohol or drug addiction 17. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 18. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
Where it's running
-
CLINICA CIURANA Centre Dental
Castelldefels, Barcelona, Spain Recruiting
Study contacts
- Study coordinator: Federica Ruggeri
- Email: federica.ruggeri@complifegroup.com
- Phone: +39 0382 25504
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.