PeriodontitisNCT04137419
Probiotics as Adjunct to Nonsurgical Periodontal Treatment
A study testing Probiotic lozenges in people with Periodontitis, run by University of Ljubljana at 1 site in Slovenia.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Probiotic lozenges
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 Nov 2018to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial
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.
- Conditions
- Periodontitis
- Being tested
- Probiotic lozenges, Placebo
- Keywords
- Periodontitis, Probiotic, Non-surgical therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic lozengesDietary supplement
Also called ProlacSan
Probiotic strains
PlaceboOther
Similar to ProlacSan lozenges in taste in colour
| Study group | Role | What they receive |
|---|---|---|
| ProlacSan | Experimental | Patient will get ProlacSan lozenges after nonsurgical treatment of periodontitis. Receives: Dietary Supplement: Probiotic lozenges |
| Placebo | Placebo comparator | Patients will get placebo lozenges after nonsurgical periodontal treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual diseased site number
No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment
Measured: 3 months
Gingival bleeding index
Percentage od bleeding sites after gentle probing of gingival sulcus
Measured: 3 months
Secondary outcomes (3)
Probing pocket depth reduction
Change in probing pocket depth
Measured: 3 months
Recession
Change of the position of the gingival margin
Measured: 3 months
Bleeding on probing
Bleeding after measurement of pocket depth
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start11 Nov 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rok Gašperšič, PhD, Principal investigator, Assist. prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137419
- Sponsor's protocol ID
- 2019-2-1
- Status last verified
- Apr 2020
- First submitted
- 16 Oct 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial
- ClinicalTrials.gov ID
- NCT04137419
- Acronym / sponsor ID
- 2019-2-1
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Probiotic, Non-surgical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProlacSan | Experimental | Dietary Supplement: Probiotic lozengesPatient will get ProlacSan lozenges after nonsurgical treatment of periodontitis. |
| Placebo | Placebo comparator | Other: PlaceboPatients will get placebo lozenges after nonsurgical periodontal treatment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic lozengesAlso: ProlacSanProbiotic strains | Dietary supplement | ProlacSan |
| PlaceboSimilar to ProlacSan lozenges in taste in colour | Other | Placebo |
Primary outcome
Residual diseased site number
Time frame: 3 months
No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment
Gingival bleeding index
Time frame: 3 months
Percentage od bleeding sites after gentle probing of gingival sulcus
3 secondary outcomes
Probing pocket depth reduction
Time frame: 3 months
Recession
Time frame: 3 months
Bleeding on probing
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rok Gašperšič, PhD principal investigator
Assist. prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic lozenges in people with Periodontitis, run by University of Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual diseased site number (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.