NCT02609061

Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Government Dental College and Research Institute, Bangalore · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Furcation Defects

Interventions

Type	Name	Description
PROCEDURE	Open flap debridement (OFD)	Open flap debridement (OFD) alone
PROCEDURE	OFD with Platelet rich fibrin (PRF)	Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
PROCEDURE	OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form	Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-11-20
• Last updated: 2015-11-20

Locations

1 site across 1 country: India