HealthyNCT07685782

A Randomized, Comparative Study to Evaluate the Effect of RL3014A-DP0421 Mouthwash on the Oral Microbial Composition

A study testing RL3014A - DP0421, CO3014AZ and CO3014AY in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The Laboratoires Pierre Fabre has on the market a product range of daily use mouthwash, all containing 0.05% of O-Cymen -5-ol, a broad-spectrum bactericide. From other mouth rinses (reference mouthwash) it is known that they have a clear effect on the microbial composition of the tongue and saliva samples. Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: RL3014A - DP0421, CO3014AZ and CO3014AY
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 sitePoland
Study dates: 29 Feb 2024to 28 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

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 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Criteria related to the population:
For woman of childbearing potential:
Use of an effective method of contraception, as assessed by the investigator for at least 1 month before the selection visit (3 months in case of hormonal con-traception)
Accept to go on using it during the whole duration of the study
Subject having been compliant to the toothpaste and toothbrush use according to the investigator and still willing to follow it
Criteria related to the teeth condition:

Show all 37Show fewer

Subject still having a healthy gum status according to the investigator
Subject still having at least 20 natural teeth specially tooth 12, 16, 24, 36, 32 and 44
Subject still not edentulous
Criteria related to the products:
Subject whose performed his/her last teeth brushing either the evening before the inclusion visit (if the inclusion visit is performed in the morning) or in the morning of the inclusion visit (if the inclusion visit is performed in the afternoon).
Non-inclusion criteria
Criteria related to the population:
For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship since the selection visit
Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
Subject who is currently participating, who plans to participate or who has participated since the selection visit in another clinical study liable to interfere with the study assessments according to the investigator's assessment
Introduction of smoking habits (cigarettes and/or user of electronic cigarette) since the selection visit
Subject having eaten or drunk alcohol, tea or coffee within 4 hours prior to the inclusion visit
Criteria related to the medical history / teeth condition:
Subject with hypersensitivity or allergy or intolerance to any of the study products ingredients since the selection visit
Subject with hypersensitivity or allergy or intolerance to any material used for the research since the selection visit
Subject with active teeth decay since the selection visit
Subject with missing teeth since the selection visit
Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel in the mouth liable to interfere with study data according to the investigator since the selection visit
Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease since the selection visit
Subject having occlusal overload or occlusal adjustment recently made on teeth since the selection visit
Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator, especially herpes or medical history herpes, aphtous and medical history of aphtous, lichen planus, chronic lupus erythematosis, sores or mouth ulcer since the selection visit
Subject with an odontological condition (like xerostomia,..), an acute chronic or progressive disease or history of disease since the selection visit considered by the investigator hazardous for the subject or incompatible with the study (like immune system disorder, asthma crisis…),
Criteria related to treatments and/or products:
Surgery, chemical or physical treatment in the mouth liable to interfere with study data according to the investigator assessment since the selection visit or planned during the study
Systemic or topical antibiotics in the mouth liable to interfere with study data according to the investigator assessment within since the selection visit or planned during the study
Systemic treatment/product or topical treatment/product in the mouth liable to interfere with study data according to the investigator assessment, especially: acetylsalicylic acid or derivatives, anti-inflammatories and other analgesic, antihistaminics, corticosteroids, immunosuppressants, calcic inhibitors and anticonvulsants since the selection visit or planned during the study
Subject having had a dental care since the selection visit or planned during the study
Any other concomitant treatment or product considered by the investigator liable to in-terfere with the study data or incompatible with the study requirements or hazardous for the subject taken or applied since the selection visit
Subject having use another toothpaste and/or toothbrush than study products since the selection visit
Subject having use a mouthwash since the selection visit

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Poland1 site

EUROFINS Dermscan Poland Sp. z o.o.
Gdansk, Poland, 80288

Other trials in Poland

About this study

Official title: A Randomized, Comparative Study to Evaluate the Effect of a RL3014A-DP0421 Mouthwash Containing Antiplaque Active Ingredient O-cymen-5-ol on the Oral Microbial Composition

The aim of the study is to evaluate if the product RL3014A - DP0421 respects the buccal flora and does not show an undesired effect on the microbial equilibrium of the mouth.

Read the detailed description

This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.

Study population: Adults with healthy gum status included and randomized in 4 parallel groups:

Group 1 (Tested group). Group with standardized hygiene and applying the tested mouthwash (RL3014A - DP0421).
Group 2 (Positive control group). Group with standardized hygiene and applying the positive control mouthwash.
Group 3 (Reference group). Group with standardized hygiene and applying the reference mouthwash.
Group 4 (Negative control group). Group with standardized hygiene only 4 visits are planned:
Visit 1: Screening (Day -14 ± 1 day).
Visit 2: Inclusion (Day 0).
Visit 3: Intermediate (Day 14 ± 1 day).
Visit 4: End of study (Day 28 ± 1 day).

The maximal duration of subject's participation is 44 days from the selection visit (visit 1) to the end of the study.

Conditions: Healthy
Being tested: RL3014A - DP0421, CO3014AZ, CO3014AY, Standardized hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RL3014A - DP0421Other
Tested product. 2 applications per day for 28 days of the tested mouthwash
CO3014AZOther
Positive control product. 2 applications per day for 28 days of the positive control mouthwash
CO3014AYOther
Reference product. 2 applications per day for 28 days of the reference mouthwash
Standardized hygieneOther
standardized hygiene with a toothpaste and a soft toothbrush provided by the sponsor and used for 44 days 2 times a day

Study groups in NCT07685782
Study group	Role	What they receive
Tested group	Experimental	Not described Receives: Other: RL3014A - DP0421; Other: Standardized hygiene
Positive control group	Active comparator	Not described Receives: Other: CO3014AZ; Other: Standardized hygiene
Reference group	Active comparator	Not described Receives: Other: CO3014AY; Other: Standardized hygiene
Negative control group	Other	Not described Receives: Other: Standardized hygiene

What is being measured

The primary outcome is the main question the study is designed to answer.

Microbiome evaluation of the back of the tongue
Tongue swab sampling (cotton-swab samples)
Measured: Visit 2 (Day 0) and Visit 4 (Day 28)
Microbiome evaluation of the saliva
Liquid saliva sampling
Measured: Visit 2 (Day 0) and Visit 4 (Day 28)
Proteomic analysis of saliva
Liquid saliva sampling
Measured: Visit 2 (Day 0) and Visit 4 (Day28)

Secondary outcomes (3)

Plaque index (TQHIP) score
Clinical assessment of the plaque using the Turesky modification of the Quigley-Hein Index performed by the dentist (scale from 0 to 5)
Measured: Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)
Modified Gingival index of Lobene
Clinical assessment of the gums state using the Modified Gingival Index of Lobene (GI) (scale from 0 to 4)
Measured: Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)
Recording of adverse events
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Measured: From Visit 1 (Day 1) to Visit 4 (Day 28 or early termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Feb 202428 Aug 2024

First posted6 Jul 2026
Study start29 Feb 2024
Primary completion28 Aug 2024
Study completion28 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07685782
Sponsor's protocol ID: RL3014A20230415
Status last verified: Jun 2026
First submitted: 25 Jun 2026
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Comparative Study to Evaluate the Effect of a RL3014A-DP0421 Mouthwash Containing Antiplaque Active Ingredient O-cymen-5-ol on the Oral Microbial Composition
ClinicalTrials.gov ID: NCT07685782
Acronym / sponsor ID: RL3014A20230415
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
Study start: 29 Feb 2024 (actual)
Primary completion: 28 Aug 2024 (actual)
Study completion: 28 Aug 2024 (actual)
First posted: 6 Jul 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 aim of the study is to evaluate if the product RL3014A - DP0421 respects the buccal flora and does not show an undesired effect on the microbial equilibrium of the mouth.

Detailed description

This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.

Study population: Adults with healthy gum status included and randomized in 4 parallel groups:

Group 1 (Tested group). Group with standardized hygiene and applying the tested mouthwash (RL3014A - DP0421).
Group 2 (Positive control group). Group with standardized hygiene and applying the positive control mouthwash.
Group 3 (Reference group). Group with standardized hygiene and applying the reference mouthwash.
Group 4 (Negative control group). Group with standardized hygiene only 4 visits are planned:
Visit 1: Screening (Day -14 ± 1 day).
Visit 2: Inclusion (Day 0).
Visit 3: Intermediate (Day 14 ± 1 day).
Visit 4: End of study (Day 28 ± 1 day).

The maximal duration of subject's participation is 44 days from the selection visit (visit 1) to the end of the study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Tested group	Experimental	Other: RL3014A - DP0421, Other: Standardized hygiene
Positive control group	Active comparator	Other: CO3014AZ, Other: Standardized hygiene
Reference group	Active comparator	Other: CO3014AY, Other: Standardized hygiene
Negative control group	Other	Other: Standardized hygiene

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (37 listed)

For woman of childbearing potential:
Subject having been compliant to the toothpaste and toothbrush use according to the investigator and still willing to follow it
Subject still having a healthy gum status according to the investigator
Subject still having at least 20 natural teeth specially tooth 12, 16, 24, 36, 32 and 44
Subject still not edentulous

Key exclusion criteria (0 listed)

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
RL3014A - DP0421Tested product. 2 applications per day for 28 days of the tested mouthwash	Other	Tested group
CO3014AZPositive control product. 2 applications per day for 28 days of the positive control mouthwash	Other	Positive control group
CO3014AYReference product. 2 applications per day for 28 days of the reference mouthwash	Other	Reference group
Standardized hygienestandardized hygiene with a toothpaste and a soft toothbrush provided by the sponsor and used for 44 days 2 times a day	Other	Negative control group, Positive control group, Reference group, Tested group

Primary outcome

Microbiome evaluation of the back of the tongue
Time frame: Visit 2 (Day 0) and Visit 4 (Day 28)
Tongue swab sampling (cotton-swab samples)
Microbiome evaluation of the saliva
Time frame: Visit 2 (Day 0) and Visit 4 (Day 28)
Liquid saliva sampling
Proteomic analysis of saliva
Time frame: Visit 2 (Day 0) and Visit 4 (Day28)
Liquid saliva sampling

3 secondary outcomes

Plaque index (TQHIP) score
Time frame: Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)
Modified Gingival index of Lobene
Time frame: Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)
Recording of adverse events
Time frame: From Visit 1 (Day 1) to Visit 4 (Day 28 or early termination)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.

Related trials for Healthy

Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils

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. This study is not recruiting at the moment.

Agata WAGNER principal investigator

EUROFINS Dermscan Poland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RL3014A - DP0421, CO3014AZ and CO3014AY in people with Healthy, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.

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 37 inclusion and 0 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiome evaluation of the back of the tongue (time frame: Visit 2 (Day 0) and Visit 4 (Day 28)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07685782.

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 6 Jul 2026.