Furcation Defects Clinical Trial
Official title:
Rosuvastatin 1.2mg in Situ Gel Combined With 1:1 Mixture of Autologous Platelet-rich Fibrin and Porus- Hydroxyappatite Bone Graft in Surgical Treatment of Mandibular Degree II Furcation Defects: A Randomized Clinical Control Trial
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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