PeriodontitisNCT02490618
The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
A study testing Probiotic tablet- Biogaia in people with Periodontitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Probiotic tablet- Biogaia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Dec 2018
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40 patients
- ≥ 18 years of age
- scaling and rootplaning received at least 3 months ago
- Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:> 5mm or 5 and BOP+
- Willing and able to give written informed consent
Who cannot join
- patients with aggressive periodontitis
- patients who smoke
- pregnant or lactating woman
- patients with poorly controlled diabetes
- patients taking bisphosphonate mediation
- patient who had taken systemic antibiotics 3 months prior to treatment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
Read the detailed description
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.
Selection of the study population: Adults, who consult at the department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.
- Conditions
- Periodontitis
- Being tested
- Probiotic tablet- Biogaia, Placebo tablet
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic tablet- BiogaiaOther
Placebo tabletOther
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Probiotic tablet Receives: Other: Probiotic tablet- Biogaia |
| Control | Placebo comparator | Control tablet Receives: Other: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket Probing Depth (PPD) at teeth with residual pockets
Measured: 3-6 months
Recessions (REC) at teeth with residual pockets
Measured: 3-6 months
Clinical Attachment Loss (CAL) at teeth with residual pockets
Measured: 3-6 months
Secondary outcomes (5)
Plaque at teeth with residual pockets
Measured: 3-6 months
Bleeding on Probing (BoP) at teeth with residual pockets
Measured: 3-6 months
Overall PPD, REC, CAL
Measured: 3-6 months
Microbial samples: deepest pocket, saliva, tongue
Measured: 3-6 months
Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionDec 2018
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490618
- Sponsor's protocol ID
- s57667
- Status last verified
- Jan 2019
- First submitted
- 6 May 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
- ClinicalTrials.gov ID
- NCT02490618
- Acronym / sponsor ID
- s57667
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Jul 2015 (estimated)
- 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.
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
Detailed description
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.
Selection of the study population: Adults, who consult at the department of Periodontology at the University Hospital Leuven, and who fit the inclusion criteria will be asked to participate in this study.
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 |
|---|---|---|
| Test | Experimental | Other: Probiotic tablet- BiogaiaProbiotic tablet |
| Control | Placebo comparator | Other: Placebo tabletControl tablet |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40 patients
- ≥ 18 years of age
- scaling and rootplaning received at least 3 months ago
- Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:> 5mm or 5 and BOP+
- Willing and able to give written informed consent
Key exclusion criteria (6 listed)
- patients with aggressive periodontitis
- patients who smoke
- pregnant or lactating woman
- patients with poorly controlled diabetes
- patients taking bisphosphonate mediation
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 tablet- Biogaia | Other | Test |
| Placebo tablet | Other | Control |
Primary outcome
Pocket Probing Depth (PPD) at teeth with residual pockets
Time frame: 3-6 months
Recessions (REC) at teeth with residual pockets
Time frame: 3-6 months
Clinical Attachment Loss (CAL) at teeth with residual pockets
Time frame: 3-6 months
5 secondary outcomes
Plaque at teeth with residual pockets
Time frame: 3-6 months
Bleeding on Probing (BoP) at teeth with residual pockets
Time frame: 3-6 months
Overall PPD, REC, CAL
Time frame: 3-6 months
Microbial samples: deepest pocket, saliva, tongue
Time frame: 3-6 months
Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)
Time frame: 3-6 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 12 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 tablet- Biogaia in people with Periodontitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 6 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 12 Feb 2019. 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 Belgium. 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?
Pocket Probing Depth (PPD) at teeth with residual pockets (time frame: 3-6 months). The study lists 3 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 12 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.