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Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL), and improve the bone level.
and the platelets concentrate has been introduced which is the injectable plasma rich fibrin (I-PRF), as it contains platelets and leukocytes, stem cells and endothelial cells that why it is called "blood concentrate ". So, it is proposed as treatment option in different periodontal procedures such as treatment of intra-bony defects,
Group I ( Experimental group): will include 12 patients undergoing open flap debridement (OFD) followed by single application of I-PRF. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.
Group II (Control group): will include 12 patients undergoing open flap debridement (OFD) followed by application of 1.2% simvastatin gel. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin 1.2%gel | Experimental | simvastatin 1.2%gel applied after open flap debridment in group I |
|
| I-prf | Experimental | Injectable plasma rich fibrin will be collected from each patient in group II and the applied after open flap debridment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Statins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index (PI) | clinical score | change from basline at 6 months |
| Gingival index (GI) | clinical score | change from basline at 6 months |
| Probing depth (PD) | clinical score | change from basline at 6 months |
| Clinical attachment level (CAL) | clinical score | change from basline at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| radiographIc | assess the alveolar bone level radiographically | from baseline at 6 months |
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Inclusion Criteria:
• Age range between 25 and 40 years
Exclusion Criteria:
• Patient with any systemic disease or conditions
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| Name | Affiliation | Role |
|---|---|---|
| suzan seif allah, professor | faculty of dentistry ainshams university | Study Director |
| ola m ezzat, ass professor | faculty of dentistry ainshams university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | New Cairo | 1234 | Egypt |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| C043309 | proliferation regulatory factors, human urine |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| injectable plasma rich fibrin | Other | I- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection |
|
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |