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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProlacSan | Experimental | Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis. |
|
| Placebo | Placebo Comparator | Patients will get placebo lozenges after nonsurgical periodontal treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic lozenges | Dietary Supplement | Probiotic strains |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rok Gašperšič, PhD | Assist. prof. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Dental Clinic | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Placebo, masked evaluator
| Placebo | Other | Similar to ProlacSan lozenges in taste in colour |
|
| Bleeding on probing | Bleeding after measurement of pocket depth | 3 months |