Effect of Probiotics on Chronic Periodontitis in Smoker and Non- Smokers

Study Overview
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Brief Summary
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Periodontitis is one of the most common chronic inflammatory disease with the etiology of bacterial plaque and is associated with a number of putative bacterial species. The periodontal destruction is substantially mediated by the host, driven by the bacterial challenge. The presence of pathogenic bacteria with the absence of so-called beneficial bacteria and the susceptibility of the host are the main aetiological factors of periodontal diseases.

Official Title
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Clinical And Microbiological Analysis Of Orally Administered Lactobacillus Probiotic Lozenges In Chronic Periodontitis Patients Among Smokers And Non-smokers And Its Correlation With Clinical Parameters - A Clinico-Microbiological Study

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: Lactobacillus brevis CD2 Lozenges


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients free from any systemic illness Previously untreated moderate to severe generalised chronic periodontitis. Patients free from adverse reactions to lactose or fermented milk products Patient unwilling to quit smoking and smokers over the past one year ( Smoker arm). Exclusion Criteria: Previous history of antibiotic usage over past 6 months Patients who are eligible for antibiotic usage during the treatment course Patients who are pregnant, lactating, alcoholic or who had undergone any surgical or nonsurgical therapy within 6 months. Acute oral lesions or necrotising ulcerative periodontitis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoker group<br>30 chronic periodontitis patients, having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks | Drug: Lactobacillus brevis CD2 Lozenges<br>* Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2<br>* Other names: Probiotics;|
| Experimental: Non-smoker<br>30 chronic periodontitis patients, not having habit of smoking, with probing pocket depth of equal or greater than 5 mm with bleeding on probing and radio-graphic evidence of bone loss in at at least 2 sites at each quadrant will be given three probiotic lozenge per day for 8 weeks | Drug: Lactobacillus brevis CD2 Lozenges<br>* Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2<br>* Other names: Probiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Clinical Periodontal Indices | Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiological indices | Porphyromonas gingivalis, Tanerella forsythus | 8 weeks |