Clinical Trial to Determine the Effect of a Mouthwash on the Preservation of the Ecology of the O… (NCT04973358) | Clinical Trial Compass
WithdrawnNot Applicable
Clinical Trial to Determine the Effect of a Mouthwash on the Preservation of the Ecology of the Oral Microbiome and Its Compatibility With Health
Stopped: funding problem
France0Started 2022-01-01
Plain-language summary
The microbiota of the human body is essential to life, and plays an essential role in the protection and development of various pathological conditions. There is a symbiotic or mutualistic relationship between humans and their microbiota. However, when the microbiota becomes dysbiotic, it is associated with pathological conditions. In the oral cavity, dysbiosis is responsible for caries and periodontal pathologies, but other associations have been demonstrated or are suspected with distant pathologies (rheumatoid arthritis, Alzheimer's disease). Mouthwashes are used therapeutically or daily to maintain oral health. The main studies reporting their effects on the ecology of the oral microbiota are for the most part limited to Pasteurian culture techniques (40% of bacteria are not yet cultivable). The advent of new generations of sequencing allows to overcome this limitation and to explore the complexity of bacterial communities, i.e. the symbiosis or dysbiosis of the entire bacterial ecosystem. The control of the oral microbiota to prevent pathologies requires a better knowledge of the oral microbial ecology and will allow the development of new approaches that consider the process of biofilm formation and the disruption of bacterial communication networks. The effects of daily mouthwash must therefore be studied at the level of the entire bacterial community.
Who can participate
Age range
18 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:
* 18 years of age or older:
* with at least 20 permanent natural teeth, excluding crowns;
* affiliated to a social security system;
* having received information about the protocol and having given their free, informed and written consent.
Exclusion Criteria:
* with periodontitis in the month prior to inclusion;
* with significant carious lesions deeply modifying the oral microbiota in the month prior to inclusion;
* having undergone oral surgical treatment within 3 months prior to inclusion;
* wearing orthodontic appliances;
* having undergone periodontal procedures in the month prior to inclusion;
* suffering from severe chronic pathologies deemed incompatible with study entry;
* allergic to one of the swab components;
* allergic to any of the components of the BUCCOTHERM mouthwash or the placebo;
* on drugs that may cause gingival hypertrophy, such as Hydantoins (phenytoin), Dihydropyridines, Diltiazem or Ciclosporin;
* Medications that can cause gingival bleeding (anticoagulants, antiplatelet agents and aspirin);
* Antibiotic therapy or professional scaling in the month prior to inclusion;
* having used oral or topical antibiotics, antiseptics and/or antifungals (e.g., mouthwash, dental gels, etc.) in the month prior to inclusion.
* Subjects with poor written and spoken French language skills;
* previously included in the BUCCOTHERM study;
* simultaneously participating in another trial that may interfere with the conduct of the BUCCOTHERM study or …
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
Commensal species of the oral microbiota
Timeframe: week 14
2
Alpha and beta diversity of the oral microbiota
Timeframe: week 14
3
Coefficient of dysbiosis/symbiosis of the oral microbiota