Probiotics as Adjunct to Nonsurgical Periodontal Treatment

NCT ID: NCT04137419

Last Updated: 2020-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-11

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Placebo, masked evaluator

Study Groups

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ProlacSan

Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis.

Group Type EXPERIMENTAL

Probiotic lozenges

Intervention Type DIETARY_SUPPLEMENT

Probiotic strains

Placebo

Patients will get placebo lozenges after nonsurgical periodontal treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Similar to ProlacSan lozenges in taste in colour

Interventions

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Probiotic lozenges

Probiotic strains

Intervention Type DIETARY_SUPPLEMENT

Placebo

Similar to ProlacSan lozenges in taste in colour

Intervention Type OTHER

Other Intervention Names

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ProlacSan

Eligibility Criteria

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Inclusion Criteria

* periodontitis stage III or IV
* at least 20 teeth for evaluation
* besides solitary crowns, no other prosthodontic tooth replacements
* good systemic health
* smoking less than 10 cig/day

Exclusion Criteria

* periodontal treatment lass than 1 year before inclusion
* antibiotic therapy in the last 6 months
* chronic systemic diseases with the impact on periodontium or healing process
* medication with the impact on periodontium or healing process
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Rok Gašperšič

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rok Gašperšič, PhD

Role: PRINCIPAL_INVESTIGATOR

Assist. prof.

Locations

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University Dental Clinic

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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2019-2-1

Identifier Type: -

Identifier Source: org_study_id

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