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Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT01870362
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
Mahatma Gandhi Post-Graduate Institute of Dental Sciences
Information provided by (Responsible Party):
CD Pharma India Pvt. Ltd.

Brief Summary:

Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.

A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.

The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Probiotic (Inersan) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis
Study Start Date : June 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Probiotic (Inersan) Arm
Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
Drug: Probiotic (Inersan)
Other Name: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2

Placebo Comparator: Placebo Arm
Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).
Drug: Placebo
Other Name: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)




Primary Outcome Measures :
  1. Improvement in periodontal indices [ Time Frame: 6 weeks, 12 weeks ]
    Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups


Secondary Outcome Measures :
  1. Microbiological indices [ Time Frame: 6 weeks, 12 weeks ]
    Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of both sexes
  • Patients in the age group of 25-60 years
  • Subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in > 30 % of the probing sites
  • The subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant)
  • Subjects in good general health

Exclusion Criteria:

  • No antibiotic therapy in the past 2 months
  • Medically compromised patients
  • Subjects who are pregnant/ lactating
  • Smokers and/or alcoholics.
  • Those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of 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): NCT01870362


Locations
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India
Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)
Puducherry, India, 605006
Sponsors and Collaborators
CD Pharma India Pvt. Ltd.
Mahatma Gandhi Post-Graduate Institute of Dental Sciences
Investigators
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Principal Investigator: Grace T Paul, MBBS, MDS Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry

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Responsible Party: CD Pharma India Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01870362     History of Changes
Other Study ID Numbers: prob-gracetpaul_01
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases