A clinical trial to study the efficacy of probiotic Lactobacillus brevis lozenges in patients with chronic periodontitis
- Registration Number
- CTRI/2009/091/000006
- Lead Sponsor
- CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New Delhi-110016, Tel.01141759898, Fax. 0114175989
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
1.Patients between 20-50 yrs of age groups.
2.Patients with chronic periodontitis with or without accompanying systemic conditions.
3.The patient should have at least 20 fully erupted teeth.
4.Patient agreeing to strictly follow study instructions and doctor?s advice for sucking the lozenges.
5.Patients ready to give written informed consent for participating in the trial.
6.Patients agreeing to comply with the study protocol and instructions.
Exclusion Criteria
1.Pregnant women and lactating mothers.
2.Has a debilitating systemic disease or disease that affects the periodontium.
3.Needs prophylactic antibodies.
4.Patients treated with antibiotic within 30 days prior to beginning of the study.
5.Is already a part of any other clinical trial or has taken any other investigational drug in the last 30 days.
6.Patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis.
7.Patients not willing to participate in the trial.
8.Patients with psychiatric disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) <br>3.Reduction in Plaque Index (PI) <br>4.Reduction in Gingival Index (GI) <br>5.Cessation of pus formation.<br>6.Improvement in clinical photograph at the time of recruitment and at the end of the study.<br>7.Reduction of clinically detectable plaque to a level compatible with periodontal health.<br>Timepoint: 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) <br>3.Reduction in Plaque Index (PI) <br>4.Reduction in Gingival Index (GI) <br>5.Cessation of pus formation.<br>7.Reduction of clinically detectable plaque to a level compatible with periodontal health.<br>Timepoint- At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks)<br>6.Improvement in clinical photograph at the time of recruitment and at the end of the study<br>Timepoint- Baseline and after 8 weeks (at end of the study)
- Secondary Outcome Measures
Name Time Method 1.Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-&#945;, IFN-&#947;) in saliva and crevicular fluid samples<br>2.Comparison of Quality of life (QoL) in test and control group <br>Timepoint: 1. Comparison of the levels of Matrixmetalloproteinases (MMPs), Nitric oxide Synthase (NOS) activity, IgA antibodies, Prostaglandin E2 (PGE2), cytokines levels (IL-1, IL-6, IL-8, TNF-&#945;, IFN-&#947;) in saliva and crevicular fluid samples<br>Timepoint- At baseline, and end of the study (after 8 weeks)<br>2.Comparison of Quality of life (QoL) in test and control group <br>Timepoint-At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks)