Probiotics as Adjunct to Nonsurgical Periodontal Treatment

Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Dietary supplement: Probiotic lozenges; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Dental Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProlacSan; Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis.	Dietary supplement: Probiotic lozenges; Probiotic strains; Other Names: ProlacSan
Placebo Comparator: Placebo; Patients will get placebo lozenges after nonsurgical periodontal treatment	Other: Placebo; Similar to ProlacSan lozenges in taste in colour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual diseased site number	No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment	3 months
Gingival bleeding index	Percentage od bleeding sites after gentle probing of gingival sulcus	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth reduction	Change in probing pocket depth	3 months
Recession	Change of the position of the gingival margin	3 months
Bleeding on probing	Bleeding after measurement of pocket depth	3 months

Collaborators and Investigators

• Sponsor: University of Ljubljana
• Investigators: Principal Investigator: Rok Gašperšič, PhD, Assist. Prof.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2018
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Periodontitis; Probiotic; Non-surgical therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 2019-2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No