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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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).
Other Name: Placebo contains all excipients except the active constituent (Lactobacillus brevis CD2)
- 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
- Microbiological indices [ Time Frame: 6 weeks, 12 weeks ]Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels
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
|Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI)|
|Puducherry, India, 605006|
|Principal Investigator:||Grace T Paul, MBBS, MDS||Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry|