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Probiotics as Adjunct to Nonsurgical Periodontal Treatment

NCT04137419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-05-01

No results posted yet for this study

Summary

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.

Conditions

  • Periodontitis

Interventions

DIETARY_SUPPLEMENT

Probiotic lozenges

Probiotic strains

OTHER

Placebo

Similar to ProlacSan lozenges in taste in colour

Sponsors & Collaborators

  • University of Ljubljana

    lead OTHER

Principal Investigators

  • Rok Gašperšič, PhD · Assist. prof.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-11
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137419 on ClinicalTrials.gov