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| Name | Class |
|---|---|
| Institut Straumann AG | INDUSTRY |
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The aim of this study is to compare surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal Surgery with EMD | Experimental | A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability. |
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| Periodontal Surgery | Active Comparator | A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periodontal surgery | Procedure | After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of C Reactive Protein (CRP) at 24 hour | CRP analyzed though blood sampling. Unit of measure: mg/L | Collected at Baseline and 24 hours in order to calculate the changes |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Pisa | Pisa | 56126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32163634 | Derived | Graziani F, Peric M, Marhl U, Petrini M, Bettini L, Tonetti M, Gennai S. Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial. J Clin Periodontol. 2020 Jun;47(6):747-755. doi: 10.1111/jcpe.13270. Epub 2020 Mar 12. |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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The examiner were not aware of group allocation
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| EMD application | Procedure | Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface |
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| Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| Triglycerides | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| HDL Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| LDL Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| Fibrinogen | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| D-Dimer | analyzed though blood sampling. Unit of measure: mg/L | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| Cystatin C | analyzed though blood sampling. Unit of measure: mg/L | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| C Reactive Protein (CRP) | CRP analyzed though blood sampling. Unit of measure: mg/L | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment |
| Clinical attachment level (CAL) at deepest site | Changes in CAL , measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 6 months after treatment |
| Pocket probing depth (PPD) at deepest site | Changes in PPD , measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 6 months after treatment |
| Recession of the gingival margin (REC) | Changes in REC, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 6 months after treatment |