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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mouthwash | Experimental | Mouthwash will be used 3 times a day after brushing during 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthwash for delicate gums | Other | Mouthwash will be used 3 times a day after brushing during 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Gingival Index Score at 4 weeks | The score is from 0 (normal gum) to 4 (severe inflammation, swelling, bleeding and presence of ulcers). | From enrolment to the end of use at 4 weeks. |
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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 Robas, Dr. | Contact | +39 0382 25504 | federica.ruggeri@complifegroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Robas | Clinica Dental Rob | Principal Investigator |
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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 13, 2026 | Apr 16, 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 |
|---|---|
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
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The participants and investigators are blind to the product that is being tested.
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| D009057 |
| Stomatognathic Diseases |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |