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the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.
Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain chitosan gel group | Placebo Comparator | After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel . |
|
| Chitosan gels containing free Simvastatin | Active Comparator | Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. . |
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| Chitosan gels containing Simvastatin microsponges | Experimental | This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open flap subgingival debridement | Procedure | After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors. |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket depth | Will be measured in millimetre | Before the beginning of study |
| Pocket depth | Will be measured in millimetre | By the end of study after 6 months of 6 months |
| Clinical attachment loss | Will be measured in millimetre | Before beginning of the study |
| Clinical attachment loss | Will be measured in millimetre | By the end of study after 6 months of 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Asyut | 71111111 | 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 |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Subgingival injection of chitosan 2% gel | Procedure | Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly |
|
| Subgingival injection of chitosan 2% gel | Procedure | Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly |
|
| Subgingival injection of chitosan 2% gel | Procedure | Group (III); injected subgingivally with placebo chitosan 2% gel weekly |
|