Mild and Moderate Chronic Periodontitis Clinical Trial
Official title:
The Effect of Probiotic Lozenge Administration on Gingivitis and on Mild & Moderate Periodontitis: A Randomized Controlled Clinical Trial.
| Verified date | July 2016 |
| Source | CD Pharma India Pvt. Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Indian Council of Medical Research |
| Study type | Interventional |
The oral cavity is mostly influenced by general health. The oral microbiota which is as complex as the gastro-intestinal or vaginal microbiota are considered to be difficult therapeutic targets. The effects of probiotics in different fields of health care have resulted recently in the introduction of probiotics for oral healthcare. Probiotics have been clinically proved effective in different fields of oral healthcare such as halitosis, oral candidiasis and tooth decay. They have also been inducted in the field of periodontal healthcare because of the current views on the etiology of plaque- related periodontal inflammation.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | May 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 50 Years |
| Eligibility |
Inclusion Criteria - Patients with chronic mild to moderate periodontitis. - Having Pocket depth > 4mm. - Mean loss of attachment, evaluated by measuring the distance from cement-enamel junction to the bottom of the probing pocket > 4mm Exclusion Criteria: - Patients on probiotic supplements - Patients who have allergy to lactose and fermented milk products - Smokers - Patients who are on antibiotic therapy or were on antibiotic therapy in the past 6 months - Patients with advanced periodontal and/or periapical conditions which necessitate immediate treatment - Patient suffering from any systemic illness - Patients who are deemed to be un-cooperative |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Department of Periodontology, Government Dental College & Hospital | Vijayawada | Andra Pradesh |
| Lead Sponsor | Collaborator |
|---|---|
| CD Pharma India Pvt. Ltd. | Government Dental College and Hospital, Vijayawada, Andra Pradesh, India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in Clinical Periodontal Indices | Improvement in clinical periodontal indices, namely, Plaque Index (PI), Gingival Index (GI), Probing Pocket Depth (PPD), Bleeding on Probing (BOP) | 8 weeks | No |
| Secondary | Improvement in Biochemical Indices | Changes in levels of Inflammatory markers, namely, Interleukin 1ß, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF) | 8 weeks | No |