Evaluation of the Effect of the Mouthwash on Delicate Gums

NCT07551908 | Not Yet Recruiting

• 1 other identifier: IT0001492/26
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

mouthwash

EXPERIMENTAL

Mouthwash will be used 3 times a day after brushing during 4 weeks.

Other: Mouthwash for delicate gums

Interventions

Mouthwash for delicate gums OTHER

Mouthwash will be used 3 times a day after brushing during 4 weeks.

mouthwash

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• % of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
• % of them with generalized gingivitis (\>30% of evaluated sites with bleeding)
• 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 informed about the test procedures who have signed a consent form and privacy agreement

You may not qualify if:

• 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
• 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)
• 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
• Subjects under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
• 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)
• Subjects admitted to a health or social facility
• Subjects planning a hospitalization during the study
• Subjects not able to be contacted in case of emergency
• Subjects deprived of freedom by administrative or legal decision or under guardianship
• Subjects who have or have had a history of alcohol or drug addiction

Sponsors & Collaborators

• Lacer S.A.: lead

MeSH Terms

Conditions

Gingivitis

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Robas

  Clinica Dental Rob

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica Robas, Dr.

CONTACT

+39 0382 25504; federica.ruggeri@complifegroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants and investigators are blind to the product that is being tested.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 27, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share