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 | Unknown

• 2 other identifiers: 35RC21_9796_BUCCOTHERM2021-A01541-40
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

mouthwash

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

BuccoTherm

EXPERIMENTAL

buccotherm mouthwash

Other: buccotherm mouthwash

Placebo

PLACEBO COMPARATOR

placebo mouthwash

Other: placebo mouthwash

Interventions

buccotherm mouthwash OTHER

twice a day for 14 weeks

BuccoTherm

placebo mouthwash OTHER

twice a day for 14 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• wearing orthodontic appliances;
• 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);
• Subjects with poor written and spoken French language skills;
• previously included in the BUCCOTHERM 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

Location

Study Officials

• Meuric Vincent

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mevel Nicolas

CONTACT

02 99 28 25 55; dri@chu-rennes.fr

Ganivet Anne

CONTACT

02 99 28 25 55; anne.ganivet@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2023
• Last Updated: August 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)