NCT07149493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 18, 2025

Last Update Submit

August 27, 2025

Conditions

Dental HygieneProbiotics, PeriodontitisPrevention of Dental CariesGingivitis and Periodontal DiseasesPeriodontal HealthOral Microbiome

Keywords

probioticsdental flossnanofiberssubgingival biofilmLigilactobacillus salivariusred complexoral microbiome

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    14 days of each intervention

Secondary Outcomes (3)

  • Detection of L. salivarius DNA in subgingival plaque

    14 days of assigned intervention

  • Quantification of red complex pathogens (P. gingivalis, T. denticola, T. forsythia)

    14 days of assigned intervention

  • Total bacterial DNA load

    14 days of assigned intervention

Study Arms (2)

Placebo Floss → Washout → Probiotic Floss

EXPERIMENTAL

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

Device: Placebo nanofiber flossDevice: Probiotic nanofiber floss

Probiotic Floss → Washout → Placebo Floss

EXPERIMENTAL

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

Device: Placebo nanofiber flossDevice: Probiotic nanofiber floss

Interventions

Placebo nanofiber flossDEVICE

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

Placebo Floss → Washout → Probiotic FlossProbiotic Floss → Washout → Placebo Floss
Probiotic nanofiber flossDEVICE

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

Placebo Floss → Washout → Probiotic FlossProbiotic Floss → Washout → Placebo Floss

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Anne's University Hospital

Brno, 65691, Czechia

Location

Related Publications (1)

  • 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 Jan 4. doi: 10.1007/s12602-025-10898-4. Online ahead of print.

    PMID: 41484513DERIVED

MeSH Terms

Conditions

PeriodontitisGingivitisPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Masking in this study was double-blind. Both participants and investigators were unaware of which type of dental floss-probiotic nanofiber floss or placebo floss-was being used during each phase of the trial. This design was implemented to minimize bias in participant behavior and outcome assessment, ensuring objective evaluation of clinical indices and microbiological results.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 2, 2025

Study Start

February 1, 2022

Primary Completion

June 24, 2022

Study Completion

June 24, 2022

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

CZ(1)