Evaluation of the Mouthwash Effect on Maintaining Healthy Microbiome in Healthy Mouth.

Evaluation of the Efficacy of a Mouthwash in Balancing Oral pH and Maintaining a Healthy Oral Microbiome.

The goal of this study is to learn if mouthwash works to maintain healthy microbiome in subjects with healthy mouth. It will also learn about its safety. The main question it aims to answer is:

• Does the mouthwash helps to maintain healthy microbiome in balance?

Participants will:

• Use mouthwash twice a day for 2 months
• Visit the clinic as scheduled per protocol for evaluations

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Mouth Microbiome
• Intervention / Treatment: Other: Mouthwash

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruggeri; Phone Number: +39 02 99025138; Email: federica.ruggeri@complifegroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy female and male subjects (without any specific repartition) subjects
2. Subjects of Caucasian ethnicity
3. Subjects aged between 18 and 55 years (extremes included)
4. Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
5. Subjects with baseline plaque index PCR ≥ 30% of surfaces with plaque according to O'Leary*
6. Subjects with ≥ 20 natural teeth and regular consumption of dietary sugars, including soft drinks, fruit juices, and other sugar-rich foods or beverages.
7. Subjects registered with the national public health system in the country where the study is conducted
8. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
9. Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
10. 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
11. Subjects who commit not to change their daily routine or lifestyle during the study
12. 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
13. 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. Subjects with active dental caries
3. Subjects with acute or chronic diseases (e.g. diabetes) able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements;
4. Subjects participating or planning to participate in other clinical trials
5. Subjects deprived of freedom by administrative or legal decision or under guardianship
6. Subjects not able to be contacted in case of emergency
7. Subjects admitted to a health or social facility
8. Subjects planning a hospitalisation during the study
9. Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
10. Subjects under pharmacological treatments that are considered incompatible (e.g. antibiotics use 3 months before the study start) with the study requirement by the investigator
11. Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
12. Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
13. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
14. Subjects who are unwilling to use only the oral health and hygiene products provided as part of the study.

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	Other: Mouthwash; Mouthwash will be used twice daily for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution from Baseline in the microbiome at 2 Months.	Microbiome evaluation would be done by 16S rRNA gene amplification	From enrollment to the end of study at 2 months

Collaborators and Investigators

• Sponsor: Lacer S.A.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 17, 2026
• First Submitted That Met QC Criteria: September 22, 2026
• First Posted (Actual): September 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 28, 2026
• Last Update Submitted That Met QC Criteria: September 22, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Cosmetics; Mouthwashes
• Other Study ID Numbers: PIT26/0000513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Only data included in the publication will be 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