Chronic Periodontitis Clinical Trial
Official title:
Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection: a Randomized, Double Masked, Placebo Controlled Clinical Trial
The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients between 21-70 years of age groups; - patients with chronic periodontitis in need of primary treatment; - patients with at least 20 fully erupted teeth; - patients ready to give written informed consent for participating in the trial; - patients agreeing to comply with the study protocol and instructions. Exclusion Criteria: - Pregnant women and lactating mothers; - patients with debilitating systemic diseases; - patients in needs for prophylactic antibiotics; - patients treated with antibiotics within 30 days prior to enrollment into the study; - patients already participant any other clinical trial or participant other investigational drug, or food supplement, in the last 30 days; - patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis; - patients not willing to participate in the trial. - patients with psychiatric problems. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Italy | University of L'Aquila, Division of Periodontology | L'aquila | AQ |
Lead Sponsor | Collaborator |
---|---|
University of L'Aquila |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs) | 6 weeks | No | |
Primary | Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2) | 6 weeks | No | |
Primary | Comparison in saliva samples of the levels of metabolic phenotype | 6 weeks | No | |
Secondary | Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity; | 6 weeks | No | |
Secondary | Comparison in saliva samples of the levels of Arginine deiminase | 6 weeks | No | |
Secondary | Comparison in saliva samples of the levels of lactoferrin | 6 weeks | No | |
Secondary | Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola) | 6 weeks | No | |
Secondary | Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide) | 6 weeks | No | |
Secondary | Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells | 6 weeks | No |
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