NCT07685782

Brief 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. RL3014A - DP0421, is the product of the range with the most representative formula. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 25, 2026

Last Update Submit

June 29, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Microbiome evaluation of the back of the tongue

    Tongue swab sampling (cotton-swab samples)

    Visit 2 (Day 0) and Visit 4 (Day 28)

  • Microbiome evaluation of the saliva

    Liquid saliva sampling

    Visit 2 (Day 0) and Visit 4 (Day 28)

  • Proteomic analysis of saliva

    Liquid saliva sampling

    Visit 2 (Day 0) and Visit 4 (Day28)

Secondary Outcomes (3)

  • Plaque index (TQHIP) score

    Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)

  • Modified Gingival index of Lobene

    Visit 2 (Day 0), Visit 3 (Day 14) and Visit 4 (Day 28)

  • Recording of adverse events

    From Visit 1 (Day 1) to Visit 4 (Day 28 or early termination)

Study Arms (4)

Tested group

EXPERIMENTAL
Other: RL3014A - DP0421Other: Standardized hygiene

Positive control group

ACTIVE COMPARATOR
Other: CO3014AZOther: Standardized hygiene

Reference group

ACTIVE COMPARATOR
Other: CO3014AYOther: Standardized hygiene

Negative control group

OTHER
Other: Standardized hygiene

Interventions

RL3014A - DP0421OTHER

Tested product. 2 applications per day for 28 days of the tested mouthwash

Tested group
CO3014AZOTHER

Positive control product. 2 applications per day for 28 days of the positive control mouthwash

Positive control group
CO3014AYOTHER

Reference product. 2 applications per day for 28 days of the reference mouthwash

Reference group
Standardized hygieneOTHER

standardized hygiene with a toothpaste and a soft toothbrush provided by the sponsor and used for 44 days 2 times a day

Negative control groupPositive control groupReference groupTested group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • 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:
  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EUROFINS Dermscan Poland Sp. z o.o.

Gdansk, Poland, 80288, Poland

Location

Study Officials

  • Agata WAGNER

    EUROFINS Dermscan Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 6, 2026

Study Start

February 29, 2024

Primary Completion

August 28, 2024

Study Completion

August 28, 2024

Last Updated

July 6, 2026

Record last verified: 2026-06

Locations

PL(1)