Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

September 25, 2016 updated by: Jorge Gamonal, University of Chile

Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP).

Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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

  • Chile
      • Santiago, Chile
        • Faculty of Dentistry of University of Chile

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

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 14 natural teeth, excluding third molars
  • 10 posterior teeth
  • 35 years old
  • 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically

Exclusion Criteria:

  • Periodontal treatment before the time of examination
  • Systemic illness
  • Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Periodontal treatment, talc powder tab
Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months
Other: Talc powder
Sachet containing talc powder and tablet containing talc powder
Procedure: Periodontal treatment Scaling and root planning
Experimental: Periodontal treatment, Probitic
Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.
Procedure: Periodontal treatment Scaling and root planning
Dietary supplement: Lactobacillus rhamnosus SP1
Sachet containing Lactobacillus rhamnosus SP1
Experimental: Periodontal treatment, Antibiotic
Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin
Procedure: Periodontal treatment Scaling and root planning
Drug: Azithromycin
Tablet containing 500mg Azithromicyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences of at least 1mm between groups for clinical attachment level changes
Time Frame: baseline, 3, 6, 9 and 12 month
baseline, 3, 6, 9 and 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences between groups for probing depth changes
Time Frame: baseline, 3, 6, 9 and 12 month
baseline, 3, 6, 9 and 12 month
Differences between groups for bleeding on probing changes
Time Frame: baseline, 3, 6, 9 and 12 month
baseline, 3, 6, 9 and 12 month
Differences between groups for plaque index changes
Time Frame: baseline, 3, 6, 9 and 12 month
baseline, 3, 6, 9 and 12 month
Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
Time Frame: baseline, 3, 6, 9 and 12 month
baseline, 3, 6, 9 and 12 month
Differences between groups for levels of periodontal pathogens changes
Time Frame: baseline, 3, 6, 9 and 12 month
baseline, 3, 6, 9 and 12 month

Collaborators and Investigators

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

Sponsor

University of Chile

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

June 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONDECYT 1130570.b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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