Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree II Furcation Defects
- Conditions
- Furcation Defects
- Interventions
- Procedure: OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel formProcedure: 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
- 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.
- 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
Group Intervention Description Group 3 OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin 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 Group 2 OFD with Platelet rich fibrin (PRF) SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
- Primary Outcome Measures
Name Time Method . Radiographic bone fill assessed in percentage baseline to 9 months assessed in percentage
- Secondary Outcome Measures
Name Time Method Relative horizontal attachment level measured in mm baseline to 9 months measured in mm
modified sulcus bleeding index baseline to 9 months 0-3 scale
Relative vertical attachment level measured in mm baseline to 9 months measured in mm
plaque index baseline to 9 months 0-3 scale
probing depth measured in mm baseline to 9 months measured in mm
Trial Locations
- Locations (1)
Government Dental College and Research Institute
🇮🇳Bangalore, Karnataka, India