Effects of Probiotic Therapy in the Treatment of Periodontitis.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of the probiotic therapy as an adjunct to non-surgical periodontal treatment in patients diagnosed with Generalized Chronic Periodontitis. Clinical study's hypothesis is that with the use of probiotic therapy, the standard treatment could be enhance.

Detailed Description
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Before the study begins, the selected individuals will be identified by a numeric code and will receive instructions regarding oral hygiene as well as supragingival scaling in all teeth. According to a random numeric table generated by a computer software, the study coordinator will allocate each patient into one of the following groups: Control (Scaling and Root Planing - SRP) or Test (SRP + probiotic therapy). The subjects (Test and Control groups) will receive lozenge containing/not containing. In the Test group, the lozenge will present Bifidobacterium lactis HN019 (HN019). Individuals will be instructed (immediately after the first session of mechanical instrumentation) to consume twice a day for 4 weeks by dissolving the lozenge before bedtime, and when wake up. They will also be instructed not to consume other probiotic product during the study. Clinical, immunological and microbiological parameters will be assessed at baseline (pre-intervention) and after completion of non-surgical periodontal therapy 30 and 90 days. All patients will receive detailed information regarding the study (goals, benefits and risks) according to the Term of Consent. The sample size was determined using the software Graphpad Statemate 2.0 (GraphPad Software, Inc., San Diego, CA, USA). The ideal sample size to ensure an 80% power in the statistical analysis of the data obtained in this study was calculated considering the differences of means and standard deviations between the test and control groups of the study by Vivekananda et al. (2010). The α value was set at 0.05. The average dropout of patients in our previous studies (approximately 20%) was also considered to calculate the sample size. Thus, a sample size of at least 30 patients was considered appropriate for this study. The normality and homoscedasticity of the data obtained will be checked. Comparisons within groups and among groups at different time intervals will be performed through parametric or non-parametric appropriate tests. The significance level will be set at 5% in all tests. All calculations will be performed by SPSS software (SPSS, Chicago IL, USA).

Official Title
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Effects of Probiotic Therapy in the Treatment of Periodontitis: a Study of Clinical, Microbiological and Immunological Profile of the Host Response.

Conditions
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Periodontitis, Probiotics

Intervention / Treatment
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* Procedure: Scaling root planning
* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 30 years old All patients must present good general health. Previously untreated periodontitis Minimum of 15 teeth Exclusion Criteria: Having received antibiotics for any purpose within 6 months prior to entering the study or the need for antibiotic coverage for dental treatment Pregnancy and nursing Acute oral lesions or necrotizing ulcerative periodontitis, A history of diabetes, rheumatic fever, liver or kidney disease, neurological deﬁciencies, immunological diseases or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, niﬁdepine, chronic use of non-steroidal anti-inﬂammatory drugs) Current smoker or former smoker

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: According to a random numeric table generated by a computer software, the study coordinator will allocate each patient into one of the following groups: Control (Scaling and Root Planing - SRP) or Test (SRP + probiotic therapy). The subjects (Control group) will receive placebo lozenge. In the Test group, the lozenge will contain Bifidobacterium lactis HN019. Individuals will be instructed (immediately after the first session of mechanical instrumentation) to consume twice a day for 4 weeks by dissolving the lozenge before bedtime and when wake up. They will also be instructed not to consume other probiotic product during the study. Clinical, immunological and microbiological parameters will be assessed at baseline (pre-intervention) and after completion of non-surgical periodontal therapy 30 and 90 days.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Scaling root planning + two lozenge per day not containing Bifidobacterium animalis lactis HN019 for 30 days. | Procedure: Scaling root planning<br>* Periodontal treatment<br>Other: Placebo<br>* two lozenge per day not containing Bifidobacterium animalis lactis HN019<br>|
| Experimental: Probiotic<br>Scaling root planning + two lozenge per day containing Bifidobacterium animalis lactis HN019 (10x9 colony-forming units) for 30 days. | Procedure: Scaling root planning<br>* Periodontal treatment<br>Dietary Supplement: Probiotic<br>* two lozenge per day containing Bifidobacterium animalis lactis HN019<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in probing depth. | millimeter. | Baseline, 30 days, 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plaque index. | sites. | Baseline, 30 days, 90 days. | 
| Changes in the levels of interleukin(IL)-1βeta, IL-8 and IL-10 in the gingival crevicular fluid. | pg/ml. | Baseline, 30 days, 90 days. | 
| Changes in the levels of immunoglobulin A in saliva. | mg/dL. | Baseline, 30 days, 90 days. | 
| Changes in the subgingival microbiota. | mean count. | Baseline, 30 days, 90 days. | 
| Changes in the expression of beta-defensin-3, toll like receptor-4, cluster of differentiation (CD)-4 and CD-8. | cells/mm2 | Baseline, 30 days. | 
| Changes in the attachment level. | millimeter. | Baseline, 30 days, 90 days. | 
| Changes in bleeding on probing. | sites. | Baseline, 30 days, 90 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Bifidobacterium animalis subsp. lactis, Periodontitis treatment, Periodontitis