Periodontitis Clinical Trial
Official title:
Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial
Verified date | April 2020 |
Source | University of Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Dental Clinic | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University of Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Residual diseased site number | No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment | 3 months | |
Primary | Gingival bleeding index | Percentage od bleeding sites after gentle probing of gingival sulcus | 3 months | |
Secondary | Probing pocket depth reduction | Change in probing pocket depth | 3 months | |
Secondary | Recession | Change of the position of the gingival margin | 3 months | |
Secondary | Bleeding on probing | Bleeding after measurement of pocket depth | 3 months |
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