Probiotics as Adjunct to Nonsurgical Periodontal Treatment

Study Overview
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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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Dietary Supplement: Probiotic lozenges
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProlacSan<br>Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis. | Dietary Supplement: Probiotic lozenges<br>* Probiotic strains<br>* Other names: ProlacSan;|
| Placebo Comparator: Placebo<br>Patients will get placebo lozenges after nonsurgical periodontal treatment | Other: Placebo<br>* Similar to ProlacSan lozenges in taste in colour<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Probiotic, Non-surgical therapy