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].
Full Title of Study: “Improvement of Periodontal Health and Reduction in Periodontal Plaque Micro-flora Using a Probiotic Lozenge in Patients With Chronic Periodontitis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: July 2014
- Drug: Probiotic (Inersan)
- Drug: Placebo
Arms, Groups and Cohorts
- Experimental: Probiotic (Inersan) Arm
- Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2
- Placebo Comparator: Placebo Arm
- Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic).
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 25 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- CD Pharma India Pvt. Ltd.
- Mahatma Gandhi Post-Graduate Institute of Dental Sciences
- Provider of Information About this Clinical Study
- Overall Official(s)
- Grace T Paul, MBBS, MDS, Principal Investigator, Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry
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