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

Phase 2

Completed

• Conditions: Three Wall Intrabony Defects in Chronic Periodontitis
• Interventions: Drug: Platelet rich fibrin and simvastatin; Biological: Platelet rich fibrin; Procedure: Open Flap Debridement alone

• Registration Number: NCT02120872
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief 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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-04
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-19
• Last Update Submitted: 2014-04-19
• Study First Posted: 2014-04-23
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF and SMV Group	Platelet rich fibrin and simvastatin	sites treated with Open Flap Debridement with Platelet Rich Fibrin along with Simvastatin
PRF Group	Platelet rich fibrin	sites treated with Open Flap Debridement with autologous Platelet Rich Fibrin
OFD Group	Open Flap Debridement alone	sites treated with Open Flap Debridement i.e. conventional flap surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plaque Index	At baseline and 9 month after surgery
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

Trial Locations

Locations (1)

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