Trial | NCT01870362  Report issue

Title

Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis
Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    28
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].
Study Started
Jun 30
2013
Primary Completion
Jul 31
2014
Study Completion
Jul 31
2014
Last Update
Jul 23
2014
Estimate

Drug Probiotic (Inersan)

  • Other names: Inersan contains not less than 1 billion CFU of Lactobacillus brevis CD2

Drug Placebo

  • Other names: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)

Probiotic (Inersan) Arm Experimental

Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2

Placebo Arm Placebo Comparator

Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).

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.
No Results Posted