Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis

June 18, 2016 updated by: Jorge Gamonal, University of Chile

Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis. Randomized Clinical Trials

The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically at baseline, 3 and 6 month after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, N=18) or control (SRP+ placebo, n=18) group. The lozenges will be used once per day during 3 month.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gingivitis is the most prevalent worldwide periodontal disease, is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss. Preventive and / or therapeutic measures to facilitate or improve their control are therefore very important, much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process. Treatment of gingivitis, like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque. Notwithstanding the foregoing, it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens, this may be only temporary since bacteria can recolonize the treated niches in the oral cavity. In this context, it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus reuteri, which possess anti-bacterial and anti-inflammatory properties. Generally speaking, probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria. Objective: To evaluate the effect of the administration of Lactobacillus reuteri as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis. Methodology: A randomized double-blind clinical trial to evaluate the effect of probiotic lozenges Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in bleeding and gingival index in the experimental group compared with the control.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Contact

Study Locations

  • Chile
      • Santiago, Chile
        • Recruiting
        • Faculty of Dentistry of University of Chile
        • Sub-Investigator:
          • Joel E Bravo Bown, Professor
        • Contact:
          • Jorge A Gamonal Aravena, Profesor
          • Phone Number: +56229781839

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

17 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Gingivitis
  • Gingival index > 1.5 (> 10 % of sites examined)
  • Bleeding index > 10 % sites surveyed
  • Probing Depth < 4 mm
  • Systemically healthy (except for the presence of gingivitis)
  • Patients who have not received periodontal treatment before the test and no intake of medicines such antibiotic and/ or anti-inflammatory in the last 3 months prior to the start of the study

Exclusion Criteria:

  • Patient who develop systemic disease during the study
  • Patient who have to ingest antibiotic/ or anti-inflammatories during the study
  • If you are a woman becomes pregnant during 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
Experimental: Treatment Gingivitis with Probiotic
Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral higiene instruction) and adjunct probiotic one lozenge containig Lactobacillus reuteri per day during 3 month
Dietary supplement: Treatment Gingivitis with Probiotic
Gingivitis Treatment (scaling and coronary polish) and one lozenge containing Lactobacillus reuteri per day during 3 months
Placebo Comparator: Treatment Gingivitis conventional
Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral higiene instruction) and one lozenge containig placebo (mint lozenge) per day during 3 month
Other: Treatment Gingivitis conventional
gingivis treatment (scaling and coronary polish) and and one lozenge containing Placebo (mint lozenge) per day during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences between groups for bleeding on probing changes
Time Frame: baseline, 1, 3 month
baseline, 1, 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences between groups for gingival index
Time Frame: baseline, 1, 3 month
baseline, 1, 3 month

Collaborators and Investigators

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

Sponsor

University of Chile

Investigators

  • Principal Investigator: Jorge Gamonal Aravena, Proffesor, Faculty of Dentistry of University of Chile

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, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 18, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1130570-Fondecyt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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