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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137419
Other study ID # 2019-2-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2018
Est. completion date April 30, 2020

Study information

Verified date April 2020
Source University of Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic lozenges
Probiotic strains
Other:
Placebo
Similar to ProlacSan lozenges in taste in colour

Locations

Country Name City State
Slovenia University Dental Clinic Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

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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