Evaluation of the Effect of the Mouthwash on Delicate Gums

Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition in Use Test Under Dentist Control.

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:

• Use mouthwash daily for 4 weeks
• Visit the clinic on the established days during 4 weeks for check-ups and evaluation

Study Overview

• Status: Not yet recruiting
• Conditions: Gingivitis
• Intervention / Treatment: Other: Mouthwash for delicate gums

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federica Robas, Dr.; Phone Number: +39 0382 25504; Email: federica.ruggeri@complifegroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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. 20% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
   2. 80% of them with generalized gingivitis (>30% of evaluated sites with bleeding)
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 intolerances or allergies to ingredients of the study product Page 8 of 28 Clinical Study Protocol: EC_0000149/2026 of 13/03/2026
10. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
11. Subjects who are currently using 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mouthwash; Mouthwash will be used 3 times a day after brushing during 4 weeks.	Other: Mouthwash for delicate gums; Mouthwash will be used 3 times a day after brushing during 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Lacer S.A.
• Investigators: Principal Investigator: Robas, Clinica Dental Rob

Study record dates

Study Major Dates

• Study Start (Estimated): April 3, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Cosmetics; Mouthwashes
• Other Study ID Numbers: IT0001492/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only summary of the results to support the publication will be shared. No complete study documents will shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No