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

NCT07685782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

OTHER

RL3014A - DP0421

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

OTHER

CO3014AZ

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

OTHER

CO3014AY

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

OTHER

Standardized hygiene

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

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Principal Investigators

  • Agata WAGNER · EUROFINS Dermscan Poland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-08-28
Completion
2024-08-28

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07685782 on ClinicalTrials.gov