CClinicalTrials.gg
Not yet recruitingNCT07844993Updated Sep 28, 2026

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

An interventional study of Mouthwash in Healthy Mouth Microbiome, sponsored by Lacer S.A.. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Lacer S.A. · Not applicable, Interventional, and Other

Updated Sep 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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
  • Visit the clinic as scheduled per protocol for evaluations
02

Conditions studied

  • Healthy Mouth Microbiome
03

In context

Lead sponsor

Lacer S.A. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    mouthwash

    Other: Mouthwash

Interventions

  • OtherMouthwash

    Mouthwash will be used twice daily for 2 months

06

What researchers measure

Primary outcomes

  1. Evolution from Baseline in the microbiome at 2 Months.

    Microbiome evaluation would be done by 16S rRNA gene amplification

    Time frame: From enrollment to the end of study at 2 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Only data included in the publication will be shared.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07844993
Lead sponsor
Lacer S.A.
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Ruggeri
Contact
federica.ruggeri@complifegroup.com
+39 02 99025138

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion