Peri-implantitisNCT02520401
The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
A study testing Probiotic - BioGaia in people with Peri-implantitis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Probiotic - BioGaia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to 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
- >18 years of age
- Patients with at least one implant* diagnosed with initial peri-implantitis.
- Willing and able to give written informed consent
- No signs of acute periodontitis
- presence of keratinized tissue around treated implant(s)
Who cannot join
- patients who smoke
- patients with periodontitis
- pregnant or lactating woman
- patients with poorly controlled diabetes
- patients taking bisphosphonate mediation
- patient who had taken systemic antibiotics 3 months prior to treatment
- peri-implantitis treatment 12 months prior intake
Trial locations and contacts
1 site in 1 country.
About this study
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
Read the detailed description
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. 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 departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this study.
- Conditions
- Peri-implantitis
- Being tested
- Probiotic - BioGaia, Placebo
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic - BioGaiaOther
Use of a probiotic tablet
PlaceboOther
Use of a placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Probiotic tablet Receives: Other: Probiotic - BioGaia |
| Control | Placebo comparator | Control tablet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Pocket Depth (PPD) at peri-implantitis sites
Pocket probing depth measured with Merrit-B probe
Measured: Baseline - 6 months
Secondary outcomes (4)
Bleeding on Probing (BoP) at peri-implantitis sites
Binairy outcome: 0: no bleeding, 1: bleeding
Measured: Baseline - 6 months
Plaque at peri-implantitis sites
Binairy outcome: 0: no plaque, 1: plaque
Measured: Baseline - 6 months
Microbial samples
Of tongue coating, saliva and peri-implantitis site
Measured: Baseline - 6 months
Full mouth plaque score (FMPS)
Binairy outcome: 0: no plaque, 1: plaque
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startOct 2015
- 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 Peri-implantitisStudies 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
- 22 participants (actual)
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
- NCT02520401
- Sponsor's protocol ID
- s57668
- Status last verified
- Jan 2018
- First submitted
- 6 May 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 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 Peri-implantitis
- ClinicalTrials.gov ID
- NCT02520401
- Acronym / sponsor ID
- s57668
- Conditions
- Peri-implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Aug 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.
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
Detailed description
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. 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 departement of Periodontology at the University Hospital Leuven, with peri-implantitis 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 - BioGaiaProbiotic tablet |
| Control | Placebo comparator | Other: PlaceboControl tablet |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years of age
- Patients with at least one implant* diagnosed with initial peri-implantitis.
- Willing and able to give written informed consent
- No signs of acute periodontitis
- presence of keratinized tissue around treated implant(s)
Key exclusion criteria (7 listed)
- patients who smoke
- patients with periodontitis
- 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 - BioGaiaUse of a probiotic tablet | Other | Test |
| PlaceboUse of a placebo tablet | Other | Control |
Primary outcome
Probing Pocket Depth (PPD) at peri-implantitis sites
Time frame: Baseline - 6 months
Pocket probing depth measured with Merrit-B probe
4 secondary outcomes
Bleeding on Probing (BoP) at peri-implantitis sites
Time frame: Baseline - 6 months
Plaque at peri-implantitis sites
Time frame: Baseline - 6 months
Microbial samples
Time frame: Baseline - 6 months
Full mouth plaque score (FMPS)
Time frame: Baseline - 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 15 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 - BioGaia in people with Peri-implantitis, 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 7 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 15 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?
Probing Pocket Depth (PPD) at peri-implantitis sites (time frame: Baseline - 6 months). 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 15 Feb 2019.