Health Condition 1: A488- Other specified bacterial diseases
Conditions
Interventions
Intervention1: Probiotic Drug Enkorinstameltcontaining 3.7 billion CFU of Streptococcus salivarius UBSS-01, Lactobacillus salivarius UBLS-22, Lactobacillus acidophilus UBLA-34, Lactobacillus rhamnosus
Sponsors
Tenshi LifeCare Pvt Ltd Bengaluru Karnataka
Padmashree Dr D Y Patil Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female volunteers of 18 to 60 years of age suffering from moderate to severe chronic periodontitis. (with at least two sites with probing pocket depth of >=3 mm and CAL >=4 mm). 2. Subjects must participate fully and be willing to comply with the procedures of the protocol. 3. Ability of subject to understand and provide voluntary, written, informed consent to participate in the study. 4. Subjects agree to not substantially change diet, medications or exercise routine.
Exclusion criteria
Exclusion criteria: 1. Patients using probiotic supplements during the past 4 weeks, prior to screening. 2. Patients on antibiotic therapy or who were on antibiotic therapy in the past1 month. 3. Patients with aggressive periodontitis. 4. Presence of excessive mobility of any tooth, which requires immediate treatment and antibiotic therapy. 5. Presence of periapical and/or periodontal abscess. 6. Patient suffering from Type II Diabetes. 7. Patients who are deemed to be uncooperative. 8. Patients on any other oral hygiene regimen other than routine tooth brushing. 9. Administration of systemic immunosuppressants in the previous 3 months, prior to screening. 10. Pregnant or lactating women. 11. Subjects with a primary or acquired immunodeficiency, including HIV seropositivity. 12. Subjects receiving or planning to receive an investigational new drug (IND) agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants. 13. Use of topical or oral complementary and alternative (CAM) agents within 4 weeks of initiation of treatment. 14. Hypersensitivity to any components contained in the probiotic capsules/sachets. 15. Individuals who are cognitively impaired and/or who are unable to give informed consent. 16. Any other condition which in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or which may pose significant risk to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing complete relief from moderate to severe chronic periodontitis after 1 month of treatmentTimepoint: Number of patients experiencing complete relief from moderate to severe chronic periodontitis after 1 month of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the change in probing pocket depth (PPD), plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and periodontal pathogen at affected sites following EnkorInstamelt treatment after one month from baselineTimepoint: Visit 1 Day 1 and Visit 3 28 days plus minus 4 days | — |
Countries
India
Contacts
Public ContactDr Atul Deshmukh
Padmashree Dr. D Y Patil University Navi Mumbai
Outcome results
None listed