Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT07149493
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2025-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Probiotic Nanofiber Floss and Subgingival Pathogen Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Approximal Plaque Index (API)', 'timeFrame': '14 days of each intervention', 'description': '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.'}, {'measure': 'Change in Sulcus Bleeding Index (SBI)', 'timeFrame': '14 days of each intervention', 'description': 'Comparison of clinical indices between pre and post probiotic OR placebo floss periods. Bleeding - 1, not bleeding - 0. Upon probing, one value per tooth.'}], 'secondaryOutcomes': [{'measure': 'Detection of L. salivarius DNA in subgingival plaque', 'timeFrame': '14 days of assigned intervention', 'description': 'Detection of L. salivarius DNA in subgingival plaque by multiplex qPCR'}, {'measure': 'Quantification of red complex pathogens (P. gingivalis, T. denticola, T. forsythia)', 'timeFrame': '14 days of assigned intervention', 'description': 'Quantification of red complex pathogens (P. gingivalis, T. denticola, T. forsythia) with multiplex qPCR'}, {'measure': 'Total bacterial DNA load', 'timeFrame': '14 days of assigned intervention', 'description': 'qPCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['probiotics', 'dental floss', 'nanofibers', 'subgingival biofilm', 'Ligilactobacillus salivarius', 'red complex', 'oral microbiome'], 'conditions': ['Dental Hygiene', 'Probiotics, Periodontitis', 'Prevention of Dental Caries', 'Gingivitis and Periodontal Diseases', 'Periodontal Health', 'Oral Microbiome']}, 'descriptionModule': {'briefSummary': '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.\n\nThis study was conducted prospectively but is being registered retrospectively to ensure transparency and compliance with NIH guidelines.', 'detailedDescription': '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.\n\nRetrospective Registration Note:\n\nThis 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male adults (≥18 years) of Czech or Slovak nationality\n* ≥20 own teeth\n* Good oral hygiene\n* Maximum Stage 2 periodontitis\n\nExclusion Criteria:\n\n* Immunocompromised status\n* Systemic illness\n* Antibiotic use within 2 months\n* Smoking\n* Probiotic use during study'}, 'identificationModule': {'nctId': 'NCT07149493', 'briefTitle': 'Probiotic Nanofiber Floss and Subgingival Pathogen Suppression', 'organization': {'class': 'OTHER', 'fullName': "St. Anne's University Hospital Brno, Czech Republic"}, 'officialTitle': 'Probiotic-containing Nanofiber-based Dental Floss Suppresses Subgingival Red Complex Periopathogens: A Randomized Double-blind Crossover Study', 'orgStudyIdInfo': {'id': 'FW02020042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo Floss → Washout → Probiotic Floss', 'description': 'Placebo Floss (Invervention 2) → Washout (14 days) → Probiotic Floss (Intervention 1)', 'interventionNames': ['Device: Placebo nanofiber floss', 'Device: Probiotic nanofiber floss']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic Floss → Washout → Placebo Floss', 'description': 'Placebo Floss (Invervention 1) → Washout (14 days) → Probiotic Floss (Intervention 2)', 'interventionNames': ['Device: Placebo nanofiber floss', 'Device: Probiotic nanofiber floss']}], 'interventions': [{'name': 'Placebo nanofiber floss', 'type': 'DEVICE', 'description': 'Identical floss without probiotic coating, used under the same conditions.', 'armGroupLabels': ['Placebo Floss → Washout → Probiotic Floss', 'Probiotic Floss → Washout → Placebo Floss']}, {'name': 'Probiotic nanofiber floss', 'type': 'DEVICE', 'description': 'Nanofiber floss infused with Ligilactobacillus salivarius (strain BCRC 14759), used twice daily for 14 days.', 'armGroupLabels': ['Placebo Floss → Washout → Probiotic Floss', 'Probiotic Floss → Washout → Placebo Floss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': "St. Anne's University Hospital", 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not discussed with the full team'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, 'collaborators': [{'name': 'Czech Technology Agency', 'class': 'UNKNOWN'}, {'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}, {'name': 'RECETOX', 'class': 'UNKNOWN'}, {'name': 'The University Hospital Brno', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}