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

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Procedure: OFD with Platelet rich fibrin (PRF); Procedure: Open flap debridement (OFD); Procedure: OFD with PRF and 1.2% Rosuvastatin

• Registration Number: NCT02645227
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief 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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Status Verified: 2016-01
• Study First Posted: 2016-01-01
• Last Update Submitted: 2016-01-01
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Systemically healthy with CP diagnosis16 having probing depth (PD) ≥5mm, clinical attachment (CA) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (IOPAR) without any antibiotic or periodontal therapy in the last 6 months.

Exclusion Criteria

• History of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufficient platelet count (<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	OFD with Platelet rich fibrin (PRF)	OFD with Platelet rich fibrin (PRF)
Group 1	Open flap debridement (OFD)	Open flap debridement (OFD)
Group 3	OFD with PRF and 1.2% Rosuvastatin	OFD with PRF and 1.2% Rosuvastatin

Primary Outcome Measures

Name	Time	Method
defect depth reduction (%)	Change from baseline to 9 months	assessed in percentage

Secondary Outcome Measures

Name	Time	Method
plaque index	Change from baseline to 9 months	scale from 0-3
probing depth (mm)	Change from baseline to 9 months	measured in mm
clinical attachment level (mm)	Change from baseline to 9 months	measured in mm
modified sulcus bleeding index	Change from baseline to 9 months	scale from 0-3

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India