Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis
Primary Purpose
Gingivitis
Status
Unknown status
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Treatment Gingivitis with Probiotic
Treatment Gingivitis conventional
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, probiotic, non- surgical treatment
Eligibility 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
Sites / Locations
- Faculty of Dentistry of University of ChileRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Gingivitis with Probiotic
Treatment Gingivitis conventional
Arm Description
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
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
Outcomes
Primary Outcome Measures
Differences between groups for bleeding on probing changes
Secondary Outcome Measures
Differences between groups for gingival index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02801773
Brief Title
Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis
Official Title
Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis. Randomized Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis, probiotic, non- surgical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Gingivitis with Probiotic
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment Gingivitis conventional
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Treatment Gingivitis with Probiotic
Intervention Description
Gingivitis Treatment (scaling and coronary polish) and one lozenge containing Lactobacillus reuteri per day during 3 months
Intervention Type
Other
Intervention Name(s)
Treatment Gingivitis conventional
Intervention Description
gingivis treatment (scaling and coronary polish) and and one lozenge containing Placebo (mint lozenge) per day during 3 months
Primary Outcome Measure Information:
Title
Differences between groups for bleeding on probing changes
Time Frame
baseline, 1, 3 month
Secondary Outcome Measure Information:
Title
Differences between groups for gingival index
Time Frame
baseline, 1, 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joel E Bravo Bown, Proffesor
Phone
+5694540294
Email
jbravo@odontologia.uchile.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Gamonal Aravena, Proffesor
Organizational Affiliation
Faculty of Dentistry of University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry of University of Chile
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge A Gamonal Aravena, Profesor
Phone
+56229781839
First Name & Middle Initial & Last Name & Degree
Joel E Bravo Bown, Professor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis
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