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| Name | Class |
|---|---|
| Government Dental College and Hospital, Vijayawada, Andra Pradesh, India | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Arm | Experimental | L. brevis CD2 Lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). Each lozenge contains at least 1 billion colony forming units of Lactobacillus brevis CD2. |
|
| Placebo Arm | Placebo Comparator | Placebo lozenges (4 lozenges per day - 1 lozenge in the morning, 1 lozenge in the afternoon and 2 lozenges in the night). The placebo lozenge contains all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Arm | Drug | Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Biochemical Indices | Changes in levels of Inflammatory markers, namely, Interleukin 1β, Matrix metalloproteinases-8 (MMP), Myeloperoxidase (MPO) and Calprotectin in Gingival Crevicular Fluid (GCF) | 8 weeks |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Surya Jyotsna Kiran Kanchumurthy, BDS | Government Dental College and Hospital, Vijayawada, Andhra Pradesh | Principal Investigator |
| Narendra Dev Jampani, MDS | Government Dental College and Hospital, Vijayawada, Andhra Pradesh | Study Director |
| Vajra Madhuri S, MDS | Government Dental College and Hospital, Vijayawada, Andhra Pradesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, Government Dental College & Hospital | Vijayawada | Andhra Pradesh | 520004 | India |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Placebo Arm | Drug | Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2) |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |