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Probiotics as Adjunct to Nonsurgical Periodontal Treatment

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Probiotic lozenges
Placebo
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Probiotic, Non-surgical therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Dental Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ProlacSan

Placebo

Arm Description

Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis.

Patients will get placebo lozenges after nonsurgical periodontal treatment

Outcomes

Primary Outcome Measures

Residual diseased site number
No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment
Gingival bleeding index
Percentage od bleeding sites after gentle probing of gingival sulcus

Secondary Outcome Measures

Probing pocket depth reduction
Change in probing pocket depth
Recession
Change of the position of the gingival margin
Bleeding on probing
Bleeding after measurement of pocket depth

Full Information

First Posted
October 16, 2019
Last Updated
April 30, 2020
Sponsor
University of Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04137419
Brief Title
Probiotics as Adjunct to Nonsurgical Periodontal Treatment
Official Title
Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Probiotic, Non-surgical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo, masked evaluator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ProlacSan
Arm Type
Experimental
Arm Description
Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will get placebo lozenges after nonsurgical periodontal treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic lozenges
Other Intervention Name(s)
ProlacSan
Intervention Description
Probiotic strains
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Similar to ProlacSan lozenges in taste in colour
Primary Outcome Measure Information:
Title
Residual diseased site number
Description
No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment
Time Frame
3 months
Title
Gingival bleeding index
Description
Percentage od bleeding sites after gentle probing of gingival sulcus
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Probing pocket depth reduction
Description
Change in probing pocket depth
Time Frame
3 months
Title
Recession
Description
Change of the position of the gingival margin
Time Frame
3 months
Title
Bleeding on probing
Description
Bleeding after measurement of pocket depth
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rok Gašperšič, PhD
Organizational Affiliation
Assist. prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Dental Clinic
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Probiotics as Adjunct to Nonsurgical Periodontal Treatment

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