The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

Study Overview
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Brief Summary
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This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.

Detailed Description
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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.

Official Title
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The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis

Conditions
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Peri-implantitis

Intervention / Treatment
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* Other: Probiotic - BioGaia
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Probiotic tablet | Other: Probiotic - BioGaia<br>* Use of a probiotic tablet<br>|
| Placebo Comparator: Control<br>Control tablet | Other: Placebo<br>* Use of a placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Pocket Depth (PPD) at peri-implantitis sites | Pocket probing depth measured with Merrit-B probe | Baseline - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing (BoP) at peri-implantitis sites | Binairy outcome: 0: no bleeding, 1: bleeding | Baseline - 6 months | 
| Plaque at peri-implantitis sites | Binairy outcome: 0: no plaque, 1: plaque | Baseline - 6 months | 
| Microbial samples | Of tongue coating, saliva and peri-implantitis site | Baseline - 6 months | 
| Full mouth plaque score (FMPS) | Binairy outcome: 0: no plaque, 1: plaque | Baseline - 6 months |