Healthy Mouth MicrobiomeNCT07844993
Evaluation of the Mouthwash Effect on Maintaining Healthy Microbiome in Healthy Mouth.
A study testing Mouthwash in people with Healthy Mouth Microbiome, run by Lacer S.A..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Mouth Microbiome
- What is being tested?
- Mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male subjects (without any specific repartition) subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 18 and 55 years (extremes included)
- Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
- Subjects with baseline plaque index PCR ≥ 30% of surfaces with plaque according to O'Leary*
- Subjects with ≥ 20 natural teeth and regular consumption of dietary sugars, including soft drinks, fruit juices, and other sugar-rich foods or beverages.
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- Subjects registered with the national public health system in the country where the study is conducted
- 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
Who cannot join
- Subjects who do not meet the inclusion criteria
- Subjects with active dental caries
- 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;
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
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- Subjects admitted to a health or social facility
- Subjects planning a hospitalisation during the study
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- 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
- 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
- Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
- Subjects who are unwilling to use only the oral health and hygiene products provided as part of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Healthy Mouth Microbiome
- Being tested
- Mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthwashOther
Mouthwash will be used twice daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| mouthwash | Experimental | Not described Receives: Other: Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution from Baseline in the microbiome at 2 Months.
Microbiome evaluation would be done by 16S rRNA gene amplification
Measured: From enrollment to the end of study at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Mouth MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844993
- Sponsor's protocol ID
- PIT26/0000513
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only data included in the publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Mouthwash in Balancing Oral pH and Maintaining a Healthy Oral Microbiome.
- ClinicalTrials.gov ID
- NCT07844993
- Acronym / sponsor ID
- PIT26/0000513
- Conditions
- Healthy Mouth Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mouthwash | Experimental | Other: Mouthwash |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy female and male subjects (without any specific repartition) subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 18 and 55 years (extremes included)
- Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
- Subjects with baseline plaque index PCR ≥ 30% of surfaces with plaque according to O'Leary*
Key exclusion criteria (14 listed)
- Subjects who do not meet the inclusion criteria
- Subjects with active dental caries
- 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;
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MouthwashMouthwash will be used twice daily for 2 months | Other | mouthwash |
Primary outcome
Evolution from Baseline in the microbiome at 2 Months.
Time frame: From enrollment to the end of study at 2 months
Microbiome evaluation would be done by 16S rRNA gene amplification
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. Only data included in the publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash in people with Healthy Mouth Microbiome, run by Lacer S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruggeri (+39 02 99025138, federica.ruggeri@complifegroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution from Baseline in the microbiome at 2 Months. (time frame: From enrollment to the end of study at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.