NCT02120872

Platelet Rich Fibrin Combined With Simvastatin for Treatment of Intrabony Defect in Chronic Periodontitis

Platelet - Rich Fibrin Combined With 1.2mg Simvastatin for the Treatment of 3 - Wall Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Three Wall Intrabony Defects in Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	Platelet rich fibrin and simvastatin	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.
BIOLOGICAL	Platelet rich fibrin	Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.
PROCEDURE	Open Flap Debridement alone	Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-04-23
• Last updated: 2014-04-23

Locations

1 site across 1 country: India