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The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the treatment of three wall intrabony defects in comparison to OFD alone.
90 systemically healthy subjects were divided randomly into three groups (30 subjects in each group, per subject one site). Control group consisted of the sites treated with OFD and test groups sites were treated with OFD with autologous PRF or PRF with SMV. Site-specific plaque index (PI), sulcus bleeding index (mSBI), probing depth (PD), relative attachment level (RAL) and intrabony defect (IBD) depth reduction was measured at baseline and 9 month after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRF and SMV Group | Active Comparator | sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin |
|
| PRF Group | Sham Comparator | sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin |
|
| OFD Group | Other | sites treated with Open Flap Debridement i.e. conventional flap surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich fibrin and simvastatin | Drug | Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure of the study was defect depth reduction evaluated radiographically | At baseline and 9 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth | At baseline and 9 month after surgery | |
| Relative Attachment Level | At baseline and 9 month after syrgery | |
| modified Sulcul Bleeding Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avani R Pradeep, MDS | Government Dental College and Research Institute, Bangalore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Government Dental College and Research Institute | Bangalore | Karnataka | 560002 | India |
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| Platelet rich fibrin | Biological | Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect. |
|
| Open Flap Debridement alone | Procedure | Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect. |
|
| At baseline and 9 month after surgery |
| Plaque Index | At baseline and 9 month after surgery |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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