Trials / Completed

CompletedNCT07149493

Probiotic Nanofiber Floss and Subgingival Pathogen Suppression

Probiotic-containing Nanofiber-based Dental Floss Suppresses Subgingival Red Complex Periopathogens: A Randomized Double-blind Crossover Study

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 33 (actual)

Sponsor: St. Anne's University Hospital Brno, Czech Republic · Academic / Other
Sex: Male
Age: 18 Years
Healthy volunteers: Accepted

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. 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.

Conditions

Interventions

Type	Name	Description
DEVICE	Placebo nanofiber floss	Identical floss without probiotic coating, used under the same conditions.
DEVICE	Probiotic nanofiber floss	Nanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days.

Timeline

Start date: 2022-02-01
Primary completion: 2022-06-24
Completion: 2022-06-24
First posted: 2025-09-02
Last updated: 2025-09-02

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT07149493. Inclusion in this directory is not an endorsement.