Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree II Furcation Defects

Platelet Rich Fibrin Combined With 1.2% Atorvastatin Gel in Treatment of Mandibular Degree II Furcation Defects: a Randomized Controlled Clinical Trial

The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.

Study Overview

• Status: Completed
• Conditions: Furcation Defects
• Intervention / Treatment: Procedure: Open flap debridement (OFD); Procedure: OFD with Platelet rich fibrin (PRF); Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form

Detailed Description

Background: A variety of regenerative materials have been tried since many years for the treatment of furcation defects. Platelet-rich fibrin (PRF), a pool reservoir of platelet concentrate with growth factors and Atorvastatin (ATV), a potent member of statin group are known to promote periodontal tissue regeneration. The aim of the present study is to explore the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II furcation defects in comparison to PRF and open flap debridement (OFD) alone.

Methods: Eighty two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1.2% ATV gel (Group 3).Clinical parameters like probing depth (PD), relative vertical clinical attachment level (RVCAL), relative horizontal clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were recorded at baseline and 9 months post-operatively. The radiological assessment of bone defect fill was done at baseline and 9 months, using computer-aided software.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2; Phase 3

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: 28 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
• No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

• Aggressive periodontitis patients
• Systemic conditions known to affect the periodontal status;
• Medications known to affect the outcomes of periodontal therapy;
• Hematological disorders and insufficient platelet count (<100,000/mm3);
• Pregnancy/lactation;
• Smoking and tobacco use in any form
• Immunocompromised individuals;
• Those having unacceptable oral hygiene (plaque index [PI] >1.5).
• Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect	Procedure: Open flap debridement (OFD); Open flap debridement (OFD) alone
Active Comparator: Group 2; SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect	Procedure: OFD with Platelet rich fibrin (PRF); Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
Active Comparator: Group 3; SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect	Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form; Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
. Radiographic bone fill assessed in percentage	assessed in percentage	baseline to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing depth measured in mm	measured in mm	baseline to 9 months
Relative vertical attachment level measured in mm	measured in mm	baseline to 9 months
Relative horizontal attachment level measured in mm	measured in mm	baseline to 9 months
modified sulcus bleeding index	0-3 scale	baseline to 9 months
plaque index	0-3 scale	baseline to 9 months

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 23, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Furcation Defects; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014U