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

Rennes University Hospital

Status: Unknown

Conditions: Buccal Microbiota

Treatments: Other: placebo mouthwash; Other: buccotherm mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT04973358

2021-A01541-40 (Other Identifier)

35RC21_9796_BUCCOTHERM

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

BuccoTherm

Experimental group

Description:

buccotherm mouthwash

Treatment:

Other: buccotherm mouthwash

Placebo

Placebo Comparator group

Description:

placebo mouthwash

Treatment:

Other: placebo mouthwash