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

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.

Study Overview

• Status: Completed
• Conditions: Three Wall Intrabony Defects in Chronic Periodontitis
• Intervention / Treatment: Drug: Platelet rich fibrin and simvastatin; Biological: Platelet rich fibrin; Procedure: Open Flap Debridement 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560002
      • Government Dental College and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with the diagnosis of chronic periodontitis
• presence of three walled intrabony defects (IBD) ≥ 3 mm deep (distance between alveolar crest and base of the defect on intraoral periapical radiograph [IOPA])
• interproximal probing depth (PD) ≥ 5 mm following scaling and root planing (SRP) in asymptomatic tooth

Exclusion Criteria:

• Subjects, with the diagnosis of aggressive periodontitis,
• with known systemic illness and taking medications known to affect the outcomes of periodontal therapy
• insufficient platelet count (< 200,000/mm3),
• pregnancy / lactation
• use of any form of tobacco
• unacceptable oral hygiene (if plaque index [PI] (Silness & Loe 1964) >1.5) after the reevaluation of phase I therapy
• teeth with furcation defects
• non-vital
• mobility of tooth ≥ Grade II

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRF and SMV Group; sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin	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.
Sham Comparator: PRF Group; sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin	Biological: Platelet rich fibrin; Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.
Other: OFD Group; sites treated with Open Flap Debridement i.e. conventional flap surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome measure of the study was defect depth reduction evaluated radiographically	At baseline and 9 month after surgery

Secondary Outcome Measures

Outcome Measure	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	At baseline and 9 month after surgery
Plaque Index	At baseline and 9 month after surgery

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore
• Investigators: Principal Investigator: Avani R Pradeep, MDS, Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: April 19, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: April 19, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2011-2012/E