Effects of Probiotic Therapy in the Treatment of Periodontitis.

January 23, 2018 updated by: Michel Reis Messora, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Ribeirão Preto, SP, Brazil, 14040-904
        • School of Dentistry of Ribeirão Preto - University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in plaque index.
Time Frame: Baseline, 30 days, 90 days.
sites.
Baseline, 30 days, 90 days.
Changes in the levels of interleukin(IL)-1βeta, IL-8 and IL-10 in the gingival crevicular fluid.
Time Frame: Baseline, 30 days, 90 days.
pg/ml.
Baseline, 30 days, 90 days.
Changes in the levels of immunoglobulin A in saliva.
Time Frame: Baseline, 30 days, 90 days.
mg/dL.
Baseline, 30 days, 90 days.
Changes in the subgingival microbiota.
Time Frame: Baseline, 30 days, 90 days.
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.
Time Frame: Baseline, 30 days.
cells/mm2
Baseline, 30 days.
Changes in the attachment level.
Time Frame: Baseline, 30 days, 90 days.
millimeter.
Baseline, 30 days, 90 days.
Changes in bleeding on probing.
Time Frame: Baseline, 30 days, 90 days.
sites.
Baseline, 30 days, 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Michel R Messora, Phd, University of Sao Paulo - FORP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 30, 2016

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06278012.1.0000.5419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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