Dental HygieneNCT07149493
Probiotic Nanofiber Floss and Subgingival Pathogen Suppression
A study testing Probiotic nanofiber floss in people with Dental Hygiene and Probiotics, Periodontitis, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
This randomized, double-blind, crossover clinical trial evaluated the effect of a probiotic-containing nanofiber dental floss on subgingival red complex periopathogens and gingival health in periodontally healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Hygiene, Probiotics, Periodontitis, Prevention of Dental Caries
- What is being tested?
- Probiotic nanofiber floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2022to 24 Jun 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male adults (≥18 years) of Czech or Slovak nationality
- ≥20 own teeth
- Good oral hygiene
- Maximum Stage 2 periodontitis
Who cannot join
- Immunocompromised status
- Systemic illness
- Antibiotic use within 2 months
- Smoking
- Probiotic use during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotic-containing Nanofiber-based Dental Floss Suppresses Subgingival Red Complex Periopathogens: A Randomized Double-blind Crossover Study
This randomized, double-blind, crossover clinical trial evaluated the effect of a probiotic-containing nanofiber dental floss on subgingival red complex periopathogens and gingival health in periodontally healthy individuals. Thirty male participants underwent two 14-day flossing interventions (probiotic floss and placebo floss), separated by a 14-day washout period. Clinical and microbiological parameters were assessed using standardized indices and multiplex qPCR.
This study was conducted prospectively but is being registered retrospectively to ensure transparency and compliance with NIH guidelines.
Read the detailed description
The study aimed to validate a targeted subgingival delivery method using Ligilactobacillus salivarius-infused nanofiber floss. Participants received both floss types in a crossover design. Clinical parameters (Approximal Plaque Index and Sulcus Bleeding Index) and microbiological markers (presence of L. salivarius, red complex pathogens, total bacterial DNA) were measured at multiple timepoints. DNA analysis was performed using validated multiplex qPCR protocols. Statistical analysis included non-parametric tests and correlation models. The study was ethically approved and conducted prospectively, but is being registered retrospectively to ensure transparency and support future publication.
Retrospective Registration Note:
This study was originally designed as a method validation investigation to refine subgingival probiotic delivery techniques using a newly developed nanofibre dental floss containing Ligilactobacillus salivarius. At the time of ethics approval and initiation (February 2022), the study was not classified as a clinical trial. However, subsequent interpretation of NIH guidelines suggests that the randomized, blinded, crossover design involving a health-related behavioral intervention meets criteria for interventional clinical research. Accordingly, the investigators now recognize that the study should be registered as a clinical trial. The research team is submitting this retrospective registration to ensure transparency and support future publication. No participant-level outcomes have been modified post hoc, and all data were collected prospectively under full ethical oversight.
- Conditions
- Dental Hygiene, Probiotics, Periodontitis, Prevention of Dental Caries, Gingivitis and Periodontal Diseases, Periodontal Health, Oral Microbiome
- Being tested
- Placebo nanofiber floss, Probiotic nanofiber floss
- Keywords
- probiotics, dental floss, nanofibers, subgingival biofilm, Ligilactobacillus salivarius, red complex, oral microbiome
- Medical subject headings
- Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo nanofiber flossDevice
Identical floss without probiotic coating, used under the same conditions.
Probiotic nanofiber flossDevice
Nanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Floss → Washout → Probiotic Floss | Experimental | Placebo Floss (Invervention 2) → Washout (14 days) → Probiotic Floss (Intervention 1) Receives: Device: Placebo nanofiber floss; Device: Probiotic nanofiber floss |
| Probiotic Floss → Washout → Placebo Floss | Experimental | Placebo Floss (Invervention 1) → Washout (14 days) → Probiotic Floss (Intervention 2) Receives: Device: Placebo nanofiber floss; Device: Probiotic nanofiber floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Approximal Plaque Index (API)
Comparison of clinical indices between pre and post probiotic OR placebo floss periods. Plaque present - 1, not present - 0. Assessment using a probe, one value per tooth.
Measured: 14 days of each intervention
Change in Sulcus Bleeding Index (SBI)
Comparison of clinical indices between pre and post probiotic OR placebo floss periods. Bleeding - 1, not bleeding - 0. Upon probing, one value per tooth.
Measured: 14 days of each intervention
Secondary outcomes (3)
Detection of L. salivarius DNA in subgingival plaque
Detection of L. salivarius DNA in subgingival plaque by multiplex qPCR
Measured: 14 days of assigned intervention
Quantification of red complex pathogens (P. gingivalis, T. denticola, T. forsythia)
Quantification of red complex pathogens (P. gingivalis, T. denticola, T. forsythia) with multiplex qPCR
Measured: 14 days of assigned intervention
Total bacterial DNA load
qPCR
Measured: 14 days of assigned intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Feb 2022
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
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 Dental HygieneStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Technology Agency, Ministry of Health, Czech Republic, RECETOX, Brno University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149493
- Sponsor's protocol ID
- FW02020042
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not discussed with the full team
Publications
Hromcik F, Holochova P, Bohm J, Kuzelova Kostakova E, Pokorny Z, Ruzicka F, Borilova Linhartova P. Probiotic-Containing Nanofiber-Based Dental Floss Suppresses Subgingival Red Complex Periopathogens: A Randomized Double-Blind Crossover Trial. Probiotics Antimicrob Proteins. 2026 Jun;18(5):6662-6675. doi: 10.1007/s12602-025-10898-4. Epub 2026 Jan 4.
PubMed 41484513
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic-containing Nanofiber-based Dental Floss Suppresses Subgingival Red Complex Periopathogens: A Randomized Double-blind Crossover Study
- ClinicalTrials.gov ID
- NCT07149493
- Acronym / sponsor ID
- FW02020042
- Conditions
- Dental Hygiene, Probiotics, Periodontitis, Prevention of Dental Caries, Gingivitis and Periodontal Diseases, Periodontal Health, Oral Microbiome
- Keywords
- probiotics, dental floss, nanofibers, subgingival biofilm, Ligilactobacillus salivarius, red complex, oral microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Czech Technology Agency, Ministry of Health, Czech Republic, RECETOX, Brno University Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 2 Sep 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.
This randomized, double-blind, crossover clinical trial evaluated the effect of a probiotic-containing nanofiber dental floss on subgingival red complex periopathogens and gingival health in periodontally healthy individuals. Thirty male participants underwent two 14-day flossing interventions (probiotic floss and placebo floss), separated by a 14-day washout period. Clinical and microbiological parameters were assessed using standardized indices and multiplex qPCR.
This study was conducted prospectively but is being registered retrospectively to ensure transparency and compliance with NIH guidelines.
Detailed description
The study aimed to validate a targeted subgingival delivery method using Ligilactobacillus salivarius-infused nanofiber floss. Participants received both floss types in a crossover design. Clinical parameters (Approximal Plaque Index and Sulcus Bleeding Index) and microbiological markers (presence of L. salivarius, red complex pathogens, total bacterial DNA) were measured at multiple timepoints. DNA analysis was performed using validated multiplex qPCR protocols. Statistical analysis included non-parametric tests and correlation models. The study was ethically approved and conducted prospectively, but is being registered retrospectively to ensure transparency and support future publication.
Retrospective Registration Note:
This study was originally designed as a method validation investigation to refine subgingival probiotic delivery techniques using a newly developed nanofibre dental floss containing Ligilactobacillus salivarius. At the time of ethics approval and initiation (February 2022), the study was not classified as a clinical trial. However, subsequent interpretation of NIH guidelines suggests that the randomized, blinded, crossover design involving a health-related behavioral intervention meets criteria for interventional clinical research. Accordingly, the investigators now recognize that the study should be registered as a clinical trial. The research team is submitting this retrospective registration to ensure transparency and support future publication. No participant-level outcomes have been modified post hoc, and all data were collected prospectively under full ethical oversight.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Placebo Floss → Washout → Probiotic Floss | Experimental | Device: Placebo nanofiber floss, Device: Probiotic nanofiber flossPlacebo Floss (Invervention 2) → Washout (14 days) → Probiotic Floss (Intervention 1) |
| Probiotic Floss → Washout → Placebo Floss | Experimental | Device: Placebo nanofiber floss, Device: Probiotic nanofiber flossPlacebo Floss (Invervention 1) → Washout (14 days) → Probiotic Floss (Intervention 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male adults (≥18 years) of Czech or Slovak nationality
- ≥20 own teeth
- Good oral hygiene
- Maximum Stage 2 periodontitis
Key exclusion criteria (5 listed)
- Immunocompromised status
- Systemic illness
- Antibiotic use within 2 months
- Smoking
- Probiotic use during 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 |
|---|---|---|
| Placebo nanofiber flossIdentical floss without probiotic coating, used under the same conditions. | Device | Placebo Floss → Washout → Probiotic Floss, Probiotic Floss → Washout → Placebo Floss |
| Probiotic nanofiber flossNanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days. | Device | Placebo Floss → Washout → Probiotic Floss, Probiotic Floss → Washout → Placebo Floss |
Primary outcome
Change in Approximal Plaque Index (API)
Time frame: 14 days of each intervention
Comparison of clinical indices between pre and post probiotic OR placebo floss periods. Plaque present - 1, not present - 0. Assessment using a probe, one value per tooth.
Change in Sulcus Bleeding Index (SBI)
Time frame: 14 days of each intervention
Comparison of clinical indices between pre and post probiotic OR placebo floss periods. Bleeding - 1, not bleeding - 0. Upon probing, one value per tooth.
3 secondary outcomes
Detection of L. salivarius DNA in subgingival plaque
Time frame: 14 days of assigned intervention
Quantification of red complex pathogens (P. gingivalis, T. denticola, T. forsythia)
Time frame: 14 days of assigned intervention
Total bacterial DNA load
Time frame: 14 days of assigned intervention
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 2 Sep 2025.
- Derived from this study: PubMed 41484513Hromcik F, Holochova P, Bohm J, Kuzelova Kostakova E, Pokorny Z, Ruzicka F, Borilova Linhartova P. Probiotic-Containing Nanofiber-Based Dental Floss Suppresses Subgingival Red Complex Periopathogens: A Randomized Double-Blind Crossover Trial. Probiotics Antimicrob Proteins. 2026 Jun;18(5):6662-6675. doi: 10.1007/s12602-025-10898-4. Epub 2026 Jan 4.
- Individual participant dataSharing planned: Undecided. Not discussed with the full team
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic nanofiber floss in people with Dental Hygiene and Probiotics, Periodontitis, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 5 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 2 Sep 2025. 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 Czechia. 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?
Change in Approximal Plaque Index (API) (time frame: 14 days of each intervention). The study lists 2 primary outcomes in all. 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 NCT07149493, 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 2 Sep 2025.