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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gingivitis tooothpaste | Experimental |
| |
| Regular toothpaste | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gingivitis toothpaste | Other | Subjects will use the gingivitis toothpaste 2-3 times daily during 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Gingival Index at 1 month | From baseline to end of treatment at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plaque index at 1 month | From baseline to end of use at 1 month |
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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:
Subjects with dental plaque (total plaque score at inclusion ≥2)
Subjects registered with the national health service
Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
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
Subjects who commit not to change their daily routine or lifestyle during the study
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
Subjects informed about the test procedures who have signed a consent form and privacy agreement
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federica Ruggeri | Contact | +39 0382 25504 | federica.ruggeri@complifegroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLINICA CIURANA Centre Dental | Recruiting | Castelldefels | Barcelona | 08860 | Spain |
Only summary of the results to support the publication will be shared. No complete study documents will shared.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2026 | Mar 20, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C546060 | hydrated silica gel-based toothpaste |
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| Regular toothpaste | Other | Subjects will use the regular toothpaste 2-3 times daily during 4 weeks |
|
| D009057 |
| Stomatognathic Diseases |