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Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 therapy | Other |
| |
| Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel | Active Comparator |
| |
| Phase 1 therapy with atorvastatin loaded into in-situ gel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Calcium | Drug | Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth | 6 weeks | |
| Bleeding index | 6 weeks | |
| Plaque index | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of transforming growth factor in gingival crevicular fluid | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misr University for Science and Technology (MUST) | Giza | Egypt |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin Calcium | Drug | Atorvastatin loaded into in-situ gel adjunctive to scaling and debridement |
|
| Scaling and debridement only | Other | Scaling and debridement only |
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |