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

NCT ID: NCT04973358

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-09-30

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.

Conditions

Buccal Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BuccoTherm

buccotherm mouthwash

Group Type: EXPERIMENTAL

buccotherm mouthwash

Intervention Type: OTHER

twice a day for 14 weeks

Placebo

placebo mouthwash

Group Type: PLACEBO_COMPARATOR

placebo mouthwash

Intervention Type: OTHER

twice a day for 14 weeks

Interventions

buccotherm mouthwash

twice a day for 14 weeks

Intervention Type: OTHER

placebo mouthwash

twice a day for 14 weeks

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meuric Vincent

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU Rennes

Rennes, , France

Countries

France

Central Contacts

Mevel Nicolas

Role: CONTACT

dri@chu-rennes.fr

02 99 28 25 55

Ganivet Anne

Role: CONTACT

anne.ganivet@chu-rennes.fr

02 99 28 25 55

Facility Contacts

MEURIC Vincent

Role: primary

Other Identifiers

2021-A01541-40

Identifier Type: OTHER

Identifier Source: secondary_id

35RC21_9796_BUCCOTHERM

Identifier Type: -

Identifier Source: org_study_id