Periodontitis
Conditions
Keywords
Periodontitis, Probiotic, Non-surgical therapy
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.
Interventions
DIETARY_SUPPLEMENTProbiotic lozenges
Probiotic strains
OTHERPlacebo
Similar to ProlacSan lozenges in taste in colour
Sponsors
University of Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo, masked evaluator
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth reduction | 3 months | Change in probing pocket depth |
| Recession | 3 months | Change of the position of the gingival margin |
| Bleeding on probing | 3 months | Bleeding after measurement of pocket depth |
Countries
Slovenia
Outcome results
None listed