Study of Growing Biofilm by an Antiplaque Mouthrinse (NCT00838266) | Clinical Trial Compass
CompletedPhase 3
Study of Growing Biofilm by an Antiplaque Mouthrinse
France50 participantsStarted 2009-02
Plain-language summary
The objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits.
The study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. It is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy volunteer
* without caries
* with at least 20 natural teeth excluding third molars
* Women using contraceptives for at least twelve weeks and while on study
* Protected by French social security system
* Written informed consent
Exclusion Criteria:
* Pregnancy or breast feeding
* Volunteers with partial denture or orthodontic appliance
* Person protected by the law who
* Person unable to give their consent to participate to the study.
* Under aged
* Current participation in another clinical trial
* Oral pathologies
* Systemic diseases
* Volunteers allergic to of the componentst of the tested products
* Volunteers with hyposalivation or xerostomia
* Treatment with antibiotics o intestinal antiseptics within 3 month before inclusion
* Treatment with oral antiseptics within 1 month before inclusion
* Alcoholic consumption more than 20 g/day (or 2 glasses)
* Heavy smokers
* Volunteers drinking a lot of tea or coffee
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.
What they're measuring
1
Plaque index of Quickley-Hein modified by Tureski. Plaque deposits are scored on all natural teeth (except third molars) after staining.
Timeframe: Measures are done on days 5 of the two plaque growth periods