Buccal MicrobiotaBUCCOTHERMNCT04973358
Clinical Trial to Determine the Effect of a Mouthwash on the Preservation of the Ecology of the Oral Microbiome and Its Compatibility With Health
A study testing buccotherm mouthwash in people with Buccal Microbiota, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Buccal Microbiota
- What is being tested?
- buccotherm mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Buccal Microbiota
- Being tested
- buccotherm mouthwash, placebo mouthwash
- Keywords
- mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buccotherm mouthwashOther
twice a day for 14 weeks
placebo mouthwashOther
twice a day for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| BuccoTherm | Experimental | buccotherm mouthwash Receives: Other: buccotherm mouthwash |
| Placebo | Placebo comparator | placebo mouthwash Receives: Other: placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Commensal species of the oral microbiota
Change from baseline in commensal species at 14 weeks
Measured: week 14
Alpha and beta diversity of the oral microbiota
Change from baseline in alpha and beta diversity at 14 weeks
Measured: week 14
Coefficient of dysbiosis/symbiosis of the oral microbiota
Change from baseline in coefficient of dysbiosis/symbiosis at 14 weeks
Measured: week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: funding problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal MicrobiotaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meuric Vincent, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973358
- Sponsor's protocol ID
- 35RC21_9796_BUCCOTHERM
- Other IDs
- 2021-A01541-40
- Acronym
- BUCCOTHERM
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04973358
- Acronym / sponsor ID
- BUCCOTHERM / 35RC21_9796_BUCCOTHERM
- Conditions
- Buccal Microbiota
- Keywords
- mouthwash
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding problem
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BuccoTherm | Experimental | Other: buccotherm mouthwashbuccotherm mouthwash |
| Placebo | Placebo comparator | Other: placebo mouthwashplacebo mouthwash |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buccotherm mouthwashtwice a day for 14 weeks | Other | BuccoTherm |
| placebo mouthwashtwice a day for 14 weeks | Other | Placebo |
Primary outcome
Commensal species of the oral microbiota
Time frame: week 14
Change from baseline in commensal species at 14 weeks
Alpha and beta diversity of the oral microbiota
Time frame: week 14
Change from baseline in alpha and beta diversity at 14 weeks
Coefficient of dysbiosis/symbiosis of the oral microbiota
Time frame: week 14
Change from baseline in coefficient of dysbiosis/symbiosis at 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meuric Vincent principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing buccotherm mouthwash in people with Buccal Microbiota, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Commensal species of the oral microbiota (time frame: week 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.