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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement in Clinical Periodontal Indices
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Smoker group
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
Intervention: Lactobacillus brevis CD2 Lozenges (Drug)
Non-smoker
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
Intervention: Lactobacillus brevis CD2 Lozenges (Drug)
Outcomes
Primary Outcomes
Improvement in Clinical Periodontal Indices
Time Frame: 8 weeks
Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD)
Secondary Outcomes
- Change in microbiological indices(8 weeks)