Rosuvastatin Gel With 1:1 Mixture of Platelet-rich Fibrin and Bone Graft in Mandibular Degree II Furcation Defects
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional
Phase: Phase 4

Summary: 
      Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic
      statin, that stimulate bone formation in critical-size cortical bone defects adjacent to
      titanium implants, when administered locally in bone. Platelet-rich fibrin (PRF) is a
      platelet concentrate with sustained release of various growth factors, having regenerative
      potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has
      clinically satisfactory response, when used to fill periodontal intrabony defects. This
      double-masked randomized study is designed to evaluate the potency of combination of RSV
      1.2mg in situ gel with 1:1 mixture of autologous PRF and HA bone graft in the surgical
      treatment of mandibular degree II furcation defects when compared with autologous PRF and HA
      bone graft placed after open flap debridement (OFD).
    

Detailed description: 
      ABSTRACT Background: A wide range of regenerative materials have been tried in the treatment
      of furcation defects. Rosuvastatin (RSV) is a new synthetic, second-generation,
      sulfur-containing, hydrophilic statin, that stimulate bone formation in critical-size
      cortical bone defects adjacent to titanium implants, when administered locally in bone.
      Platelet-rich fibrin (PRF) is a platelet concentrate with sustained release of various growth
      factors, having regenerative potential to treat periodontal defects. Porous hydroxyapatite
      (HA) bone grafting material has clinically satisfactory response, when used to fill
      periodontal intrabony defects. This double-masked randomized study is designed to evaluate
      the potency of combination of RSV 1.2mg in situ gel with 1:1 mixture of autologous PRF and HA
      bone graft in the surgical treatment of mandibular degree II furcation defects when compared
      with autologous PRF and HA bone graft placed after open flap debridement (OFD).

      Material and methods 105 patients with mandibular buccal Class II furcation defects were
      randomly allotted and treated either with, OFD and placebo gel: Group 1, or OFD + autologous
      PRF and porus-HA bone graft: Group 2, or OFD + RSV 1.2mg in situ gel combined with autologous
      PRF and porus-HA bone graft: Group 3. Clinical parameters were recorded at baseline before
      SRP and at 9 months; they included modified sulcus bleeding index (mSBI), probing depth (PD),
      and relative vertical (RVAL) and horizontal (RHAL) attachment levels. At baseline and after 9
      months, radiographic assessment of bone defect fill was performed postoperatively.
    

Intervention name(s): Rosuvastatin; platelet rich fibrin
Intervention type(s): Drug; Biological
Intervention description(s): Rosuvastatin, is a statin group of drug.; AUTOLOGUS PLATELET GROWTH FACTOR
Other intervention name(s): statin; platelet concentrate
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: regeneration; surgical therapy; furcation defect