Effects of Probiotic Therapy in the Treatment of Periodontitis.

Phase 2

Completed

• Conditions: Probiotics; Periodontitis
• Interventions: Procedure: Scaling root planning; Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT03408548
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-08-30
• Status Verified: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-22
• Last Update Submitted: 2018-01-23
• Study First Posted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• More than 30 years old
• All patients must present good general health.
• Previously untreated periodontitis
• Minimum of 15 teeth

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Scaling root planning + two lozenge per day containing Bifidobacterium animalis lactis HN019 (10x9 colony-forming units) for 30 days.
Probiotic	Scaling root planning	Scaling root planning + two lozenge per day containing Bifidobacterium animalis lactis HN019 (10x9 colony-forming units) for 30 days.
Placebo	Scaling root planning	Scaling root planning + two lozenge per day not containing Bifidobacterium animalis lactis HN019 for 30 days.
Placebo	Placebo	Scaling root planning + two lozenge per day not containing Bifidobacterium animalis lactis HN019 for 30 days.

Primary Outcome Measures

Name	Time	Method
Changes in probing depth.	Baseline, 30 days, 90 days.	millimeter.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Dentistry of Ribeirão Preto - University of Sao Paulo; 🇧🇷 Ribeirão Preto, SP, Brazil