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Clinical and Microbiological Effects of Lactobacillus Rhamnosus 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
Jorge Gamonal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring gingivitis, probiotic, non- surgical treatment

Eligibility Criteria

17 Years - 28 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who develop systemic disease during the study.
  • Patients who have to ingest antibiotics and / or antiinflammatories 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 hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month

Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct placebo containing one sachet placebo (talc power) 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
Differences between groups for detection of periodontal pathogens
P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Differences between groups for levels of periodontal pathogens changes
P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus

Full Information

First Posted
June 13, 2016
Last Updated
October 24, 2016
Sponsor
Jorge Gamonal
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1. Study Identification

Unique Protocol Identification Number
NCT02809313
Brief Title
Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis
Official Title
Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jorge Gamonal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic sachet as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months 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 sachet will be used once per day during 3 months.
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 rhamnosus, 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 rhamnosus 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 sachet probiotic Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia and A. viscosus) in the experimental group compared with the control. Association between clinical and microbiological parameters.

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
36 (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 hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus 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 hygiene instruction) and adjunct placebo containing one sachet placebo (talc power) 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 sachet containing Lactobacillus rhamnosus SP1 per day during 3 months
Intervention Type
Other
Intervention Name(s)
Treatment Gingivitis conventional
Intervention Description
gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months
Primary Outcome Measure Information:
Title
Differences between groups for bleeding on probing changes
Time Frame
baseline, 3 month, 6 month
Secondary Outcome Measure Information:
Title
Differences between groups for gingival index
Time Frame
baseline, 3 month, 6 month
Title
Differences between groups for detection of periodontal pathogens
Description
P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Time Frame
baseline, 3 month, 6 month
Title
Differences between groups for levels of periodontal pathogens changes
Description
P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus
Time Frame
baseline, 3 month, 6 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 the sites examined) Index increased bleeding on probing 10% of the sites surveyed Probing Depth < 3 mm Systemically healthy (except for the presence of gingivitis) Patients who have not received periodontal treatment and before no intake of medicines such as antibiotics and / or anti-inflammatory in the last 3 months prior to the start of the study Exclusion Criteria: Patients who develop systemic disease during the study. Patients who have to ingest antibiotics and / or antiinflammatories 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, Profesor
Phone
+56229781839
First Name & Middle Initial & Last Name & Degree
Joel E Bravo Bown, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

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