Clinical trial NCT04973358: Clinical Trial to Determine the Effect of a Mouthwash on the Preservation of the Ecology of the Oral Microbiome and Its Compatibility With Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Buccal Microbiota
Keywords: mouthwash
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Commensal species of the oral microbiota
timeFrame: week 14
measure: Alpha and beta diversity of the oral microbiota
timeFrame: week 14
measure: Coefficient of dysbiosis/symbiosis of the oral microbiota
timeFrame: week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Meuric Vincent
role: PRINCIPAL_INVESTIGATOR
References: