Probiotics as Adjunct to Nonsurgical Periodontal Treatment
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2018
CompletedFirst Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMay 1, 2020
April 1, 2020
1.5 years
October 16, 2019
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Probing pocket depth reduction
3 months
Recession
3 months
Bleeding on probing
3 months
Study Arms (2)
ProlacSan
EXPERIMENTALPatient will get ProlacSan lozenges after nonsurgical treatment of periodontitis.
Placebo
PLACEBO COMPARATORPatients will get placebo lozenges after nonsurgical periodontal treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Dental Clinic
Ljubljana, 1000, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rok Gašperšič, PhD
Assist. prof.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo, masked evaluator
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof.
Study Record Dates
First Submitted
October 16, 2019
First Posted
October 24, 2019
Study Start
November 11, 2018
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
May 1, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share