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Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801773
Recruitment Status : Unknown
Verified June 2016 by Jorge Gamonal, University of Chile.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Gamonal, University of Chile

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gingivitis Dietary Supplement: Treatment Gingivitis with Probiotic Other: Treatment Gingivitis conventional Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis. Randomized Clinical Trials
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Differences between groups for bleeding on probing changes [ Time Frame: baseline, 1, 3 month ]

Secondary Outcome Measures :
  1. Differences between groups for gingival index [ Time Frame: baseline, 1, 3 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801773


Contacts
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Contact: Joel E Bravo Bown, Proffesor +5694540294 jbravo@odontologia.uchile.cl

Locations
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Chile
Faculty of Dentistry of University of Chile Recruiting
Santiago, Chile
Contact: Jorge A Gamonal Aravena, Profesor    +56229781839      
Sub-Investigator: Joel E Bravo Bown, Professor         
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Jorge Gamonal Aravena, Proffesor Faculty of Dentistry of University of Chile
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Responsible Party: Jorge Gamonal, Proffesor, University of Chile
ClinicalTrials.gov Identifier: NCT02801773    
Other Study ID Numbers: 1130570-Fondecyt
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jorge Gamonal, University of Chile:
gingivitis
probiotic
non- surgical treatment
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases