Microbiota-related DiseaseHIJANCT06848790
Interdental Hygiene Methods in Young Adults
A study testing Calibrated interdental brush in people with Microbiota-related Disease and Oral Hygiene, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiota-related Disease, Oral Hygiene, Periodontal Diseases
- What is being tested?
- Calibrated interdental brush
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2025to 13 Apr 2026
- 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
- Person between 18 and 30 years old
- Person who has given free, informed, express written consent
- Person affiliated to a French social security system
- Person living or working in Lyon or the Lyon conurbation served by public transport (TCL)
Who cannot join
- Person with a smoking addiction
- Person participating in another study related to oral hygiene
- Patients at high risk of infective endocarditis
- Person with chronic pathologies
- Person having taken antibiotic treatment during the month preceding the start of the study
- Pregnant, parturient or breastfeeding woman
Show all 15Show fewer
- Persons deprived of liberty by a judicial or administrative decision
- People receiving psychiatric care
- Persons admitted to a health or social establishment for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Person with fewer than 20 natural teeth
- Person performing interdental hygiene and/or daily mouthwashes.
- Person wearing orthodontic appliance
- Person with periodontal disease (stage ≥ II periodontal lesions according to the Chicago 2017 classification (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm) and/or generalized (>30% of sites )), active caries or during dental care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Methods of Interdental Space Hygiene in Daily Practice Among Young Adults: A Randomized, Single-Blind Controlled Trial
Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). These IS represent a unique ecological niche where the body has limited specific defense mechanisms, making them vulnerable to infections.
In adults, the colonization of interdental spaces by pathogenic bacteria increases the risk of periodontal diseases, which are themselves associated with non-communicable diseases such as cardiovascular diseases, diabetes, and certain types of cancer.
Preventing interdental microbiota dysbiosis from a young age is therefore a priority to maintain quality oral health and contribute to good systemic health throughout life. However, conventional brushing techniques cover only accessible tooth surfaces and cannot reach the interdental spaces. Currently, the use of interdental brushes (IDBs) is recognized as the most effective method for interdental hygiene. There are various types of IDBs, differing in several aspects that influence their effectiveness and usability. The main differences relate to their shape, size, and calibration using an interdental probe or not, allowing adaptation to different interdental space sizes. To date, only one study has demonstrated the effectiveness of daily calibrated interdental brush use in reducing dysbiosis and interdental inflammation among young adults. However, no research has yet been conducted to compare the effectiveness of the various types of IDBs available on the market (calibrated versus non-calibrated).
- Being tested
- Calibrated interdental brush
- Keywords
- Oral health, Interdental hygiene, Periodontal disease prevention, Interdental microbiota, Preventive care
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calibrated interdental brushProcedure or surgery
participants will use calibrated interdental brushes
| Study group | Role | What they receive |
|---|---|---|
| Calibrated interdental brush | Experimental | Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a calibrated interdental brushes . Receives: Procedure: Calibrated interdental brush |
| Non-calibrated interdental brush | No intervention | Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a non-calibrated interdental brushes . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interdental bleeding at month 3 (in percentage)
Comparison of interdental inflammation (interdental bleeding) following the daily use of calibrated versus non-calibrated interdental brushes at month 3 (T3, expressed as a percentage and assessed at four sites per tooth following probing with a periodontal probe).
Measured: Baseline (T0), 3 months after baseline (T3)
Secondary outcomes (5)
Composition of the Interdental microbiome (diversity and total bacteria count)
Identification of the composition of the interdental microbiome in healthy young adults using sequencing techniques at T0, in four standardized sites (between teeth 15-16, 25-26, 35-36, and 45-46). If the specified teeth are missing, exhibit pathologies, or have diastemas preventing interdental cleaning, the sample will be taken from the nearest healthy mesial interdental space.
Measured: Baseline (T0)
Periodontal health analysis
Comparison of periodontal for all participant's teeth (plaque index, gingival index, interdental inflammation, pocket depth and loss of clinical attachment) before (T0), 1 week after baseline (T1), 1 month after baseline (T2) and 3 months after baseline (T3) following the daily use of calibrated versus non-calibrated interdental brushes
Measured: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Periodontal health analysis - salivary pH
Comparison of periodontal for all participant's teeth (salivary pH) before (T0), 1 week after baseline (T1), 1 month after baseline (T2) and 3 months after baseline (T3) following the daily use of calibrated versus non-calibrated interdental brushes
Measured: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Interdental microbiota at T3 (diversity and total bacteria count)
Comparison of the composition of the interdental microbiome in healthy young adults using sequencing techniques after 3 months of calibrated versus non calibrated interdental brushed, in four standardized sites (between teeth 15-16, 25-26, 35-36, and 45-46). If the specified teeth are missing, exhibit pathologies, or have diastemas preventing interdental cleaning, the sample will be taken from the nearest healthy mesial interdental space.
Measured: Baseline (T0), 3 months after baseline (T3)
Daily use acceptability of interdental brushes
Evaluation and comparison of the acceptability and ease of integration (by TFA questionnaire) of daily use of calibrated versus non-calibrated interdental brushes, 1 week after baseline (T1), 1 month after baseline (T2) and 3 months after baseline (T3)
Measured: 1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start17 Sep 2025
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbiota-related DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane VIENNOT, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848790
- Sponsor's protocol ID
- 69HCL24_1272
- Acronym
- HIJA
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carrouel F, Lan R, Saliasi I, Bourgeois D, Benech N, Murat-Ringot A, Viennot S. Effectiveness of Different Methods of Interdental Hygiene in Daily Practice Among Young Adults: Protocol for a Randomized, Single-Blind Controlled Trial. JMIR Res Protoc. 2025 Dec 4;14:e85154. doi: 10.2196/85154.
PubMed 41343847
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Methods of Interdental Space Hygiene in Daily Practice Among Young Adults: A Randomized, Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06848790
- Acronym / sponsor ID
- HIJA / 69HCL24_1272
- Keywords
- Oral health, Interdental hygiene, Periodontal disease prevention, Interdental microbiota, Preventive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 27 Feb 2025 (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.
Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). These IS represent a unique ecological niche where the body has limited specific defense mechanisms, making them vulnerable to infections.
In adults, the colonization of interdental spaces by pathogenic bacteria increases the risk of periodontal diseases, which are themselves associated with non-communicable diseases such as cardiovascular diseases, diabetes, and certain types of cancer.
Preventing interdental microbiota dysbiosis from a young age is therefore a priority to maintain quality oral health and contribute to good systemic health throughout life. However, conventional brushing techniques cover only accessible tooth surfaces and cannot reach the interdental spaces. Currently, the use of interdental brushes (IDBs) is recognized as the most effective method for interdental hygiene. There are various types of IDBs, differing in several aspects that influence their effectiveness and usability. The main differences relate to their shape, size, and calibration using an interdental probe or not, allowing adaptation to different interdental space sizes. To date, only one study has demonstrated the effectiveness of daily calibrated interdental brush use in reducing dysbiosis and interdental inflammation among young adults. However, no research has yet been conducted to compare the effectiveness of the various types of IDBs available on the market (calibrated versus non-calibrated).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calibrated interdental brush | Experimental | Procedure: Calibrated interdental brushHealthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a calibrated interdental brushes . |
| Non-calibrated interdental brush | No intervention | –Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a non-calibrated interdental brushes . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Person between 18 and 30 years old
- Person who has given free, informed, express written consent
- Person affiliated to a French social security system
- Person living or working in Lyon or the Lyon conurbation served by public transport (TCL)
Key exclusion criteria (15 listed)
- Person with a smoking addiction
- Person participating in another study related to oral hygiene
- Patients at high risk of infective endocarditis
- Person with chronic pathologies
- Person having taken antibiotic treatment during the month preceding the start of the study
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 |
|---|---|---|
| Calibrated interdental brushparticipants will use calibrated interdental brushes | Procedure or surgery | Calibrated interdental brush |
Primary outcome
Interdental bleeding at month 3 (in percentage)
Time frame: Baseline (T0), 3 months after baseline (T3)
Comparison of interdental inflammation (interdental bleeding) following the daily use of calibrated versus non-calibrated interdental brushes at month 3 (T3, expressed as a percentage and assessed at four sites per tooth following probing with a periodontal probe).
5 secondary outcomes
Composition of the Interdental microbiome (diversity and total bacteria count)
Time frame: Baseline (T0)
Periodontal health analysis
Time frame: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Periodontal health analysis - salivary pH
Time frame: Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Interdental microbiota at T3 (diversity and total bacteria count)
Time frame: Baseline (T0), 3 months after baseline (T3)
Daily use acceptability of interdental brushes
Time frame: 1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 41343847Carrouel F, Lan R, Saliasi I, Bourgeois D, Benech N, Murat-Ringot A, Viennot S. Effectiveness of Different Methods of Interdental Hygiene in Daily Practice Among Young Adults: Protocol for a Randomized, Single-Blind Controlled Trial. JMIR Res Protoc. 2025 Dec 4;14:e85154. doi: 10.2196/85154.
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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.
Stéphane VIENNOT principal investigator
HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calibrated interdental brush in people with Microbiota-related Disease and Oral Hygiene, run by Hospices Civils de Lyon 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 15 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: finished, as of the sponsor's last update on 24 Apr 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interdental bleeding at month 3 (in percentage) (time frame: Baseline (T0), 3 months after baseline (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06848790, which also lists 1 linked publication.
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 24 Apr 2026.