MedPath

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

Phase 2
Completed
Conditions
Furcation Defects
Interventions
Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form
Procedure: Open flap debridement (OFD)
Procedure: OFD with Platelet rich fibrin (PRF)
Registration Number
NCT02612792
Lead Sponsor
Government Dental College and Research Institute, Bangalore
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
82
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 3OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel formSRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin for treating furcation defect
Group 1Open flap debridement (OFD)Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Group 2OFD with Platelet rich fibrin (PRF)SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Primary Outcome Measures
NameTimeMethod
. Radiographic bone fill assessed in percentagebaseline to 9 months

assessed in percentage

Secondary Outcome Measures
NameTimeMethod
Relative horizontal attachment level measured in mmbaseline to 9 months

measured in mm

modified sulcus bleeding indexbaseline to 9 months

0-3 scale

Relative vertical attachment level measured in mmbaseline to 9 months

measured in mm

plaque indexbaseline to 9 months

0-3 scale

probing depth measured in mmbaseline to 9 months

measured in mm

Trial Locations

Locations (1)

Government Dental College and Research Institute

🇮🇳

Bangalore, Karnataka, India

© Copyright 2025. All Rights Reserved by MedPath