Platelet Rich Fibrin+1% Alendronate in Treatment of Mandibular Degree II Furcation Defects
- Conditions
- Furcation Defects
- Interventions
- Procedure: OFD with Platelet rich fibrin (PRF)Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel formProcedure: Open flap debridement (OFD)
- Registration Number
- NCT02609061
- Lead Sponsor
- Government Dental College and Research Institute, Bangalore
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Presence of buccal Class 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.
- Systemic conditions known to affect the periodontal status;
- Medications known to affect the outcomes of periodontal therapy;
- Hematological disorders and insufficient platelet count (<200,000/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
- Aggressive periodontitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 OFD with Platelet rich fibrin (PRF) SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect Group 3 OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate for treating furcation defect Group 1 Open flap debridement (OFD) Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
- Primary Outcome Measures
Name Time Method Radiographic bone fill baseline to 9 months assessed in percentage
- Secondary Outcome Measures
Name Time Method Relative vertical attachment level baseline to 9 months measured in mm
plaque index baseline to 9 months 0-3 scale
probing depth baseline to 9 months measured in mm
Relative horizontal attachment level baseline to 9 months measured in mm
modified sulcus bleeding index baseline to 9 months 0-3 scale
Trial Locations
- Locations (1)
Government Dental College and Research Institute
🇮🇳Bangalore, Karnataka, India