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WithdrawnNCT04973358BUCCOTHERMUpdated Jun 12, 2026

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

An interventional study of buccotherm mouthwash and placebo mouthwash in Buccal Microbiota, sponsored by Rennes University Hospital. Withdrawn at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
funding problem
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Buccal Microbiota

Keywords

  • mouthwash
03

In context

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    BuccoTherm

    buccotherm mouthwash

    Other: buccotherm mouthwash

  • Placebo comparator
    Placebo

    placebo mouthwash

    Other: placebo mouthwash

Interventions

  • Otherbuccotherm mouthwash

    twice a day for 14 weeks

  • Otherplacebo mouthwash

    twice a day for 14 weeks

06

What researchers measure

Primary outcomes

  1. Commensal species of the oral microbiota

    Change from baseline in commensal species at 14 weeks

    Time frame: week 14

  2. Alpha and beta diversity of the oral microbiota

    Change from baseline in alpha and beta diversity at 14 weeks

    Time frame: week 14

  3. Coefficient of dysbiosis/symbiosis of the oral microbiota

    Change from baseline in coefficient of dysbiosis/symbiosis at 14 weeks

    Time frame: week 14

07

Study locations

1 site
  • CHU Rennes
    Rennes, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04973358
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Jul 22, 2021
Start date
Jan 1, 2022 (estimated)
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Jun 12, 2026

Study contacts

Meuric Vincent
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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