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The aim of the study to evaluate the clinical and biochemical efficacy of 1% Metformin gel in treatment of periodontitis patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% Metformin | Active Comparator | 1% Metformin Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months. |
|
| Control Group | Placebo Comparator | Placebo gel without the active ingredient. Delivered in biodegradable gel. Frequency- One dose each at baseline, 3 months and 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Locally delivered Metformin gel in the treatment of periodontitis patients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| RANKL and Osteoprotegrin levels in Gingival Crevicular Fluid before & after application of metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis. | Baseline and 1 month after the gel application |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (PI) | Baseline, 3 Months and 6 Months post operatively. | |
| Gingival Index (GI) | Baseline, 3 Months and 6 Months post operatively. | |
| Probing depth (PD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sameh Magdy Abou El-Kheir | Cairo | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2019 | Jan 3, 2024 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Evaluate the clinical parameters ( Probing Depth, Clinical Attachment Level, Gingival and Plaque Indices) before & after the application of locally delivered metformin as an adjunctive therapy to non surgical periodontal treatment of Stage III periodontitis.
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| Placebo |
| Drug |
Placebo gel consist of drug without the active component. |
|
| Baseline, 3 Months and 6 Months post operatively. |
| Clinical attachment level (CAL) | Baseline, 3 Months and 6 Months post operatively. |