PRF+1% MF for Class II Mandibular Furcation Defects
- Conditions
- Furcation Defects
- Interventions
- Procedure: OFD with Platelet rich fibrin (PRF)Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel formProcedure: Open flap debridement (OFD)
- Registration Number
- NCT03207698
- Lead Sponsor
- Government Dental College and Research Institute, Bangalore
- Brief Summary
The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
- Detailed Description
Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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 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% Metformin (Drug) in gel form SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin 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 assessed in percentage baseline to 9 months assessed in percentage
- Secondary Outcome Measures
Name Time Method probing depth measured in mm baseline to 9 months measured in mm
Relative vertical attachment level measured in mm baseline to 9 months measured in mm
Relative horizontal attachment level measured in mm baseline to 9 months measured in mm
plaque index baseline to 9 months 0-3 scale
modified sulcus bleeding index baseline to 9 months 0-3 scale
Trial Locations
- Locations (1)
Government Dental College and Research Institute
🇮🇳Bangalore, Karnataka, India