Clinical Trial to Determine the Effect of a Mouthwash on the Preservation of the Ecology of the Oral Microbiome and Its Compatibility With Health

Study Overview
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Brief Summary
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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.

Official Title
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BUCCOTHERM : Randomized Clinical Trial to Determine the Effect of a Mouthwash on the Preservation of the Ecology of the Oral Microbiome and Its Compatibility With Health

Conditions
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Buccal Microbiota

Intervention / Treatment
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* Other: buccotherm mouthwash
* Other: placebo mouthwash


Participation Criteria
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Eligibility Criteria
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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 in a period of exclusion after participation in another clinical study; protected persons (adults under legal protection (legal guardianship, curatorship, tutorship), persons deprived of liberty, pregnant or breastfeeding women, women of childbearing age without effective contraception (estrogen-progestin treatments, IUD, tubal ligation), minors.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BuccoTherm<br>buccotherm mouthwash | Other: buccotherm mouthwash<br>* twice a day for 14 weeks<br>|
| Placebo Comparator: Placebo<br>placebo mouthwash | Other: placebo mouthwash<br>* twice a day for 14 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Commensal species of the oral microbiota | Change from baseline in commensal species at 14 weeks | week 14 | 
| Alpha and beta diversity of the oral microbiota | Change from baseline in alpha and beta diversity at 14 weeks | week 14 | 
| Coefficient of dysbiosis/symbiosis of the oral microbiota | Change from baseline in coefficient of dysbiosis/symbiosis at 14 weeks | week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mouthwash