The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy

Conditions
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Periodontitis

Intervention / Treatment
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* Other: Probiotic tablet- Biogaia
* Other: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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 tablet- Biogaia<br> <br> |
| Placebo Comparator: Control<br>Control tablet | Other: Placebo tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket Probing Depth (PPD) at teeth with residual pockets |  | 3-6 months | 
| Recessions (REC) at teeth with residual pockets |  | 3-6 months | 
| Clinical Attachment Loss (CAL) at teeth with residual pockets |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque at teeth with residual pockets |  | 3-6 months | 
| Bleeding on Probing (BoP) at teeth with residual pockets |  | 3-6 months | 
| Overall PPD, REC, CAL |  | 3-6 months | 
| Microbial samples: deepest pocket, saliva, tongue |  | 3-6 months | 
| Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) |  | 3-6 months |