NCT02645227

Platelet-rich Fibrin With 1.2% Rosuvastatin in Chronic Periodontitis Treatment

Platelet-rich Fibrin With 1.2% Rosuvastatin for the Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1.2% Rosuvastatin (RSV) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients

Detailed description

ABSTRACT Background: Regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. The hypolipidaemic Statin group of drugs, particularly Rosuvastatin (RSV), are known to be associated with alveolar bone formation and periodontal improvements. Platelet analogues like Platelet rich fibrin (PRF), being rich sources of growth factors, have also come into widespread periodontal regenerative use. The aim of the study is to evaluate and compare the efficacy of open-flap debridement (OFD) with or without PRF or PRF + 1.2% RSV gel in the treatment of intrabony defects (IBDs) in chronic periodontitis (CP) patients. Methods: Ninety individuals with a total of 90 IBDs were randomly assigned to one of the 3 treatment groups: 1) OFD alone, 2) OFD + PRF and 3) OFD + PRF + 1.2% RSV gel placement. Plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment (CA) level and IBD depth were recorded at baseline and at 9 months post-operatively.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Open flap debridement (OFD)	Oral prophylaxis followed by OFD for treating bone defect
PROCEDURE	OFD with Platelet rich fibrin (PRF)	Oral prophylaxis followed by OFD with PRF placement into the bone defect
PROCEDURE	OFD with PRF and 1.2% Rosuvastatin	Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2016-01-01
• Last updated: 2016-01-05

Locations

1 site across 1 country: India