A randomized, double blind, placebo controlled study of efficacy of Lactobacillus CD2 lozenges in patients with chronic periodontitis
Trial Snapshot
- Phase
- Phase 2/3
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation.6.Improvement in clinical photograph at the time of recruitment and at the end of the study.7.Reduction of clinically detectable plaque to a level compatible with periodontal health.
Study Overview
Brief Summary
This study is a randomized, double blind, parallel group, single-centre trial to study the efficacy of the probiotic Lactobacillus CD2 Lozenges (INERSAN) in chronic periodontitis patients.The primary endpoints are reduction in Community Periodontal Index (CPI), Reduction in Sulcus bleeding Index (SBI),Reduction in Plaque Index (PI),Reduction in Gingival Index (GI),Cessation of pus formatioImprovement in clinical photograph at the time of recruitment and at the end of the study and Reduction of clinically detectable plaque to a level compatible with periodontal health. The secondary endponts are 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-α, IFN-γ) in saliva and crevicular fluid samples and Comparison of Quality of life (QoL) in test and control group.
Study Design
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria1.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
- •Exclusion Criteria1.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.
Outcomes
Primary Outcomes
1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation.6.Improvement in clinical photograph at the time of recruitment and at the end of the study.7.Reduction of clinically detectable plaque to a level compatible with periodontal health.
Time Frame: 1.Reduction in Community Periodontal Index (CPI) 2.Reduction in Sulcus bleeding Index (SBI) 3.Reduction in Plaque Index (PI) 4.Reduction in Gingival Index (GI) 5.Cessation of pus formation.7.Reduction of clinically detectable plaque to a level compatible with periodontal health.Timepoint- At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks)6.Improvement in clinical photograph at the time of recruitment and at the end of the studyTimepoint- Baseline and after 8 weeks (at end of the study)
Secondary Outcomes
- 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-α, IFN-γ) in saliva and crevicular fluid samples2.Comparison of Quality of life (QoL) in test and control group(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-α, IFN-γ) in saliva and crevicular fluid samplesTimepoint- At baseline, and end of the study (after 8 weeks)2.Comparison of Quality of life (QoL) in test and control group Timepoint-At baseline, after 4 weeks and end of the study (Total study Duration-8 weeks))