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| Name | Class |
|---|---|
| Mahatma Gandhi Postgraduate Institute of Dental Sciences | OTHER |
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Periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. Following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. Periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products.
A few studies have revealed that probiotic Lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including Porphyromonas gingivalis (Pg), in the saliva and sub-gingival plaque. Concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (SRP), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing.
The aim of the present study is to evaluate the improvement of periodontal health with probiotic (Inersan) lozenges, used as an adjunct to scaling and root planing [SRP].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic (Inersan) Arm | Experimental | Inersan Lozenges (2 Lozenges bid). Each probiotic lozenge contains not less than 1 billion CFU of L. brevis CD2 |
|
| Placebo Arm | Placebo Comparator | Placebo Lozenges (2 lozenges bid). Placebo lozenge contains only excipients (without probiotic). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic (Inersan) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in periodontal indices | Improvement in Periodontal indices, namely, plaque index [PI], Gingival index [GI], Gingival bleeding index [GBI], probing pocket depth [PPD] and clinical attachment levels [CAL] in both groups | 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological indices | Changes in pathogen (Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Prevotella intermedia) levels | 6 weeks, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace T Paul, MBBS, MDS | Mahatma Gandhi Post- Graduate Institute of Dental Sciences, Pondicherry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mahatma Gandhi Post Graduate Institute of Dental Sciences (MGPGI) | Puducherry | Puducherry | 605006 | India |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Drug |
|
|
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |