Clinical Trial: Platelet Rich Fibrin+1% Alendronate 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% Alendronate Gel in Treatment of Mandibular Degree II Furcation Defects: A Randomized Controlled Clinical Trial

Brief Summary: The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.

Detailed Summary:

Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.

Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated at baseline and 9 months.


Sponsor: Government Dental College and Research Institute, Bangalore

Current Primary Outcome: Radiographic bone fill [ Time Frame: baseline to 9 months ]

assessed in percentage


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • probing depth [ Time Frame: baseline to 9 months ]
    measured in mm
  • Relative vertical attachment level [ Time Frame: baseline to 9 months ]
    measured in mm
  • Relative horizontal attachment level [ 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 15, 2015
Date Started: January 2015
Date Completion:
Last Updated: November 17, 2015
Last Verified: November 2015