A Randomized, Comparative Study to Evaluate the Effect of RL3014A-DP0421 Mouthwash on the Oral Mi… (NCT07685782) | Clinical Trial Compass
CompletedNot Applicable
A Randomized, Comparative Study to Evaluate the Effect of RL3014A-DP0421 Mouthwash on the Oral Microbial Composition
Poland109 participantsStarted 2024-02-29
Plain-language 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.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Selection
Criteria related to the population:
* Subject female aged between 18 to 35 years included
* Subject having signed his/her written informed consent for his/her participation in the study
* Subject affiliated to a social security system or health insurance, or is a beneficiary (if required by national regula-tions)
* 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 contraception)
* Accept to go on using it during the whole duration of the study
* having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
* certifying the truth of the personal information declared to the Investigator
* able to understand the language used in the investigation center and the information given
* able to comply with the protocol and follow protocol's constraints and specific requirements
Criteria related to subject's health:
\- considered "healthy subject" by the Investigator
Criteria related to subject's oral health:
* Subject with a healthy gum status according to the investigator
* Subject with at least 20 natural teeth specially tooth 12, 16, 24, 36, 32 and 44 (If one of these teeth is missing, it will be replaced by a similar natural tooth (i.e. replacement of a molar by another molar) on the same jaw)
* Subjects with no edentulous
Non-selection criteria
Criteria r…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.