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Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

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ClinicalTrials.gov Identifier: NCT02809313
Recruitment Status : Unknown
Verified June 2016 by Jorge Gamonal, University of Chile.
Recruitment status was:  Recruiting
First Posted : June 22, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Gamonal, University of Chile

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.

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis: a Randomized Placebo-controlled Trials With 3-month Follow-up
Study Start Date : March 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : November 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 hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month
Dietary Supplement: Treatment Gingivitis with Probiotic
gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months

Placebo Comparator: Treatment Gingivitis conventional
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
Other: Treatment Gingivitis conventional
gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months




Primary Outcome Measures :
  1. Differences between groups for bleeding on probing changes [ Time Frame: baseline, 3 month, 6 month ]

Secondary Outcome Measures :
  1. Differences between groups for gingival index [ Time Frame: baseline, 3 month, 6 month ]
  2. Differences between groups for detection of periodontal pathogens [ Time Frame: baseline, 3 month, 6 month ]
    P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus

  3. Differences between groups for levels of periodontal pathogens changes [ Time Frame: baseline, 3 month, 6 month ]
    P. gingivalis, A. actinomicetemcomitans, T. forsythia and A. viscosus



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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 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.

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): NCT02809313


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, Profesor    +56229781839      
Sub-Investigator: Joel E Bravo Bown, Professor         
Sponsors and Collaborators
Jorge Gamonal
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, Professor, University of Chile
ClinicalTrials.gov Identifier: NCT02809313     History of Changes
Other Study ID Numbers: 1130570
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: October 26, 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