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)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Buccal Microbiota
• Intervention / Treatment: Other: buccotherm mouthwash; Other: placebo mouthwash

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mevel Nicolas; Phone Number: 02 99 28 25 55; Email: dri@chu-rennes.fr
• Study Contact Backup: Name: Ganivet Anne; Phone Number: 02 99 28 25 55; Email: anne.ganivet@chu-rennes.fr

Study Locations

• France
  • Rennes, France
    • CHU Rennes
    • Contact: MEURIC Vincent
    • Sub-Investigator: BONNAURE-MALLET Martine
    • Sub-Investigator: BOYER Emile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BuccoTherm; buccotherm mouthwash	Other: buccotherm mouthwash; twice a day for 14 weeks
Placebo Comparator: Placebo; placebo mouthwash	Other: placebo mouthwash; twice a day for 14 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Meuric Vincent, CHU Rennes

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: mouthwash
• Other Study ID Numbers: 35RC21_9796_BUCCOTHERM; 2021-A01541-40 (Other Identifier: N° IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No