Probiotic Nanofiber Floss and Subgingival Pathogen Suppression

NCT ID: NCT07149493

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-06-24

Brief 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

Dental Hygiene; Probiotics, Periodontitis; Prevention of Dental Caries; Gingivitis and Periodontal Diseases; Periodontal Health; Oral Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo Floss → Washout → Probiotic Floss

Placebo Floss (Invervention 2) → Washout (14 days) → Probiotic Floss (Intervention 1)

Group Type: EXPERIMENTAL

Placebo nanofiber floss

Intervention Type: DEVICE

Identical floss without probiotic coating, used under the same conditions.

Probiotic nanofiber floss

Intervention Type: DEVICE

Nanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days.

Probiotic Floss → Washout → Placebo Floss

Placebo Floss (Invervention 1) → Washout (14 days) → Probiotic Floss (Intervention 2)

Group Type: EXPERIMENTAL

Placebo nanofiber floss

Intervention Type: DEVICE

Identical floss without probiotic coating, used under the same conditions.

Probiotic nanofiber floss

Intervention Type: DEVICE

Nanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days.

Interventions

Placebo nanofiber floss

Identical floss without probiotic coating, used under the same conditions.

Intervention Type: DEVICE

Probiotic nanofiber floss

Nanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male adults (≥18 years) of Czech or Slovak nationality
• ≥20 own teeth
• Good oral hygiene
• Maximum Stage 2 periodontitis

Exclusion Criteria

• Immunocompromised status
• Systemic illness
• Antibiotic use within 2 months
• Smoking
• Probiotic use during study

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Czech Technology Agency

UNKNOWN

Sponsor Role: collaborator

Ministry of Health, Czech Republic

OTHER_GOV

Sponsor Role: collaborator

RECETOX

UNKNOWN

Sponsor Role: collaborator

The University Hospital Brno

UNKNOWN

Sponsor Role: collaborator

St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St. Anne's University Hospital

Brno, , Czechia

Countries

Czechia

Other Identifiers

FW02020042

Identifier Type: -

Identifier Source: org_study_id