Probiotics as Adjunct to Nonsurgical Periodontal Treatment

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Dietary Supplement: Probiotic lozenges; Other: Placebo

• Registration Number: NCT04137419
• Lead Sponsor: University of Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-11
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-24
• Status Verified: 2020-04
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProlacSan	Probiotic lozenges	Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis.
Placebo	Placebo	Patients will get placebo lozenges after nonsurgical periodontal treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recession	3 months	Change of the position of the gingival margin
Bleeding on probing	3 months	Bleeding after measurement of pocket depth
Probing pocket depth reduction	3 months	Change in probing pocket depth

Trial Locations

Locations (1)

University Dental Clinic; 🇸🇮 Ljubljana, Slovenia