NCT04137419 is a NA clinical trial of Probiotic lozenges in Periodontitis, sponsored by University of Ljubljana.

Who is sponsoring NCT04137419?

NCT04137419 is sponsored by University of Ljubljana.

What drugs are being tested in NCT04137419?

Interventions in NCT04137419: Probiotic lozenges, Placebo.

What condition does NCT04137419 study?

NCT04137419 studies Periodontitis.

Is NCT04137419 still recruiting?

NCT04137419 is currently completed. Last updated 1 May 2020.

Last reviewed 2020-05-01 · How we verify

NCT04137419

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Probiotics as Adjunct to Nonsurgical Periodontal Treatment

Completed NA Last updated 1 May 2020

What this trial tests

NA trial testing Probiotic lozenges in Periodontitis in 40 participants. Completed in 30 April 2020.

Timeline

11 November 2018

Primary endpoint
30 April 2020

30 April 2020

Quick facts

Lead sponsor	University of Ljubljana
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	11 November 2018
Primary completion	30 April 2020
Estimated completion	30 April 2020
Sites	1 location across Slovenia

Drugs / interventions tested

Probiotic lozenges — full drug profile →
Placebo

Conditions studied

Periodontitis — all drugs for Periodontitis →

Sponsor

University of Ljubljana

Who can join

Adults 20 to 65, any sex, with Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. Before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. One lozenge per day of probiotic/placebo will be used during 3 months healing period. Primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth \> 4 mm and bleeding on probing.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Recent advances in therapeutic probiotics: insights from human trials.
Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24

Verify or expand the search:

Other trials of Probiotic lozenges

Trials testing the same drug.

NCT04653714 — The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery · NA · completed
NCT04199897 — Effect of a 2-week Sugar Stress on Bacterial Profiles in Whole Saliva · NA · completed

Other recruiting trials for Periodontitis

Currently open trials in the same condition.

NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
NCT07535177 — Gas6 and Soluble MerTK in Periodontal Diseases · recruiting
NCT07491848 — Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D · recruiting
NCT07421960 — Investigation of the Relationship Between Periodontitis and Sleep Quality · recruiting
NCT07532694 — Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients · NA · recruiting

Other University of Ljubljana trials

Trials by the same sponsor.

NCT07418632 — Kinematic Training in Patients With Neck Pain Based on Machine Learning Classification Approach · NA · recruiting
NCT07425613 — Cervical Movement Control Before and After Anterior Cervical Discectomy and Fusion · NA · recruiting
NCT07237321 — Peripheral Magnetic Stimulation of Foot Muscles: Effects on Medial Longitudinal Arch Height and Foot Muscle Strength in · NA · not yet recruiting
NCT06669715 — Evaluation of Physical Fitness and Hemodynamics Across a Diverse Population · recruiting
NCT06692595 — Digital PCR for Quantifying Periodontal Pathobionts · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04137419 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Ljubljana
Last refreshed: 1 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04137419.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing