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

NCT04973358 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-08-27

No results posted yet for this study

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

Interventions

OTHER

buccotherm mouthwash

twice a day for 14 weeks

OTHER

placebo mouthwash

twice a day for 14 weeks

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Meuric Vincent · CHU Rennes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-10-31
Completion
2023-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973358 on ClinicalTrials.gov