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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Government Dental College and Research Institute, Bangalore

Current Primary Outcome: . Radiographic bone fill assessed in percentage [ Time Frame: baseline to 9 months ]

assessed in percentage


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • probing depth measured in mm [ Time Frame: baseline to 9 months ]
    measured in mm
  • Relative vertical attachment level measured in mm [ Time Frame: baseline to 9 months ]
    measured in mm
  • Relative horizontal attachment level measured in mm [ Time Frame: baseline to 9 months ]
    measured in mm
  • modified sulcus bleeding index [ Time Frame: baseline to 9 months ]
    0-3 scale
  • plaque index [ Time Frame: baseline to 9 months ]
    0-3 scale


Original Secondary Outcome: Same as current

Information By: Government Dental College and Research Institute, Bangalore

Dates:
Date Received: November 20, 2015
Date Started: December 2014
Date Completion:
Last Updated: November 23, 2015
Last Verified: November 2015