Rosuvastatin 1.2 mg In Situ Gel Combined With 1:1 Mixture of Autologous Platelet-Rich Fibrin and Porous Hydroxyapatite Bone Graft in Surgical Treatment of Mandibular Class II Furcation Defects: A Randomized Clinical Control Trial
- Autores: A.R. Pradeep, Shruti Karvekar, Kanika Nagpal, Kaushik Patnaik, Arjun Raju, Priyanka Singh
- Localización: Journal of periodontology, ISSN 0022-3492, Vol. 87, Nº. 1, 2016, págs. 5-13
- Idioma: inglés
- Enlaces
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Resumen
Background: A wide range of regenerative materials have been tried and tested in the treatment of furcation defects. Rosuvastatin (RSV) is a new synthetic, second-generation, sulfur-containing, hydrophilic statin with potent anti-inflammatory and osseodifferentiation mechanisms of action. Platelet-rich fibrin (PRF) is a platelet concentrate having sustained release of various growth factors with regenerative potential to treat periodontal defects. Porous hydroxyapatite (HA) bone grafting material has a clinically satisfactory response when used to fill periodontal intrabony defects. This double-masked randomized study is designed to evaluate the potency of a combination of 1.2 mg RSV in situ gel with a 1:1 mixture of autologous PRF and HA bone graft in the surgical treatment of mandibular Class II furcation defects compared with autologous PRF and HA bone graft placed after open-flap debridement (OFD).
Methods: One hundred five mandibular furcation defects were treated with OFD + placebo gel (group 1), PRF + HA with OFD (group 2), or 1.2 mg RSV gel + PRF + HA with OFD (group 3). Clinical and radiologic parameters (i.e., probing depth [PD], relative vertical and relative horizontal clinical attachment level [rvCAL and rhCAL], intrabony defect depth, and percentage of defect fill) were recorded at baseline and 9 months postoperatively.
Results: Mean PD reduction was greater in group 2 (3.68 ± 1.07 mm) and group 3 (4.62 ± 1.03 mm) than group 1 (2.11 ± 1.25 mm), and mean rvCAL and rhCAL gain were greater in group 2 (3.31 ± 0.52 and 2.97 ± 0.56 mm, respectively) and group 3 (4.17 ± 0.70 and 4.05 ± 0.76 mm) compared with group 1 (1.82 ± 0.78 and 1.62 ± 0.64 mm). A significantly greater percentage of mean bone fill was found in group 2 (54.69% ± 1.93%) and group 3 (61.94% ± 3.54%) compared with group 1 (10.09% ± 4.28%).
Conclusions: Treatment of furcation defects with 1.2 mg RSV in situ gel combined with autologous PRF and porous HA bone graft results in significant improvements of clinical and radiographic parameters compared with OFD alone. These results imply that the combination of RSV, PRF, and HA has synergistic effects, explaining their role as a regenerative material in the treatment of furcation defects.
Periodontal disease affects the periodontal apparatus, i.e., cementum, periodontal ligament, and alveolar bone, as a sequela of subgingival plaque accumulation, leading to inflammatory conditions caused by microbial infection and unbalanced host immune responses to a triggering mediator in biofilm.1 Periodontal breakdown that involves the intersection of multirooted teeth (i.e., molars with furcation) has been reported to have a greater inflammatory component, thus reacting less favorably to periodontal therapy, than molars without furcation involvement or single-rooted teeth.2 This inaccessible anatomy of the furcation space3 makes periodontal therapy a challenging task because of the impediment in routine oral hygiene maintenance and even professional root debridement.4 Surgical access to the interradicular space appreciably promotes complete calculus removal and restoration of furcation defects with regenerative materials such as bone grafts, including autografts,5 demineralized freeze-dried bone allografts,6 bovine-derived xenografts,7 guided tissue/bone regeneration methods with barrier membranes,8 and combinations of membranes and bone grafts.9 Bone deficiencies and clinical attachment loss within the furcation areas are of major concern; thus the use of new biomimetic materials such as enamel matrix derivatives,10 platelet-rich plasma,11 platelet-derived growth factor (PDGF),12 bone morphogenetic proteins,10 and the statin group of drugs (e.g., atorvastatin13 and simvastatin14) has shown considerable improvements in periodontal regeneration. Each regenerative agent has its own unique regenerative potency, as shown in the literature.5,8,10-12 Choukroun platelet-rich fibrin (PRF),15 a second-generation platelet concentrate, is a close congregation of platelets, cytokines, structural glycoproteins, and glycan chains entangled in a complex fibrin meshwork that can be used as fibrin membrane enriched with platelets and growth factors (PDGF and transforming growth factor [TGF]-β).16,17 The significant slow, persistent release of key growth factors for ≥1 week and ≤28 days has well-known additive effects on the healing process.18 Numerous beneficial effects are reported, such as osteoconductive filling material in sinus-lift procedures,19 facial plastic surgery,20 and multiple gingival recession treatment;21 bone tissue engineering;22 and treatment of mandibular Class II furcation defects.23 Porous hydroxyapatite (HA) bone grafts, used to fill periodontal intrabony defects, permit outgrowth of osteogenic cells from existing bone surfaces into the adjacent bone material24 with clinically acceptable responses.25 The graft is osteoconductive and well tolerated, and allergic reactions are absent, since it has no organic components.26 Porous HA promotes bone formation at defect sites, whereas its true periodontal regeneration ability is controversial.27 Rosuvastatin (RSV)§ is a highly efficient competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG CoA) reductase, with a potent role in reducing serum cholesterol concentrations, thereby diminishing the threat of cardiovascular accident. RSV is a sulfur-containing, synthetic, second-generation hydrophilic statin.28 Its potent anti-inflammatory action is due to increased nitric oxide production that inhibits P selectin synthesis by endothelial cells,29 as evidenced by reduced levels of high-sensitivity C-reactive protein.30 Regenerative potential of RSV is demonstrated by bone morphogenetic protein (BMP)-2 expression and enhanced alkaline phosphatase (ALP) activity observed in stages of osteoblastic differentiation.31 RSV, being hydrophilic in nature, depends on solute carrier (SLC) to cross the cell membrane in mature osteoblasts to begin its action.32 It is also reported to enhance bone formation when administered locally in critical-size cortical bone defects around implants.33 Apart from this, RSV has local actions: antiplatelet aggregation,34 reduction of oxidative stress,35 and restoration of superoxide dismutase (SOD)-1 expression.36 In a previous study,37 the present authors reported greater decreases in pocket depth (PD), greater gains in clinical attachment level (CAL), and greater bone fill in intrabony defects (IBDs) with autologous PRF and porous HA bone graft treatment versus controls. Studies have shown beneficial effects of atorvastatin13 and simvastatin14 when administered in Class II furcation defects.38 With the notion that combining all these regenerative materials may yield a synergistic effect, in the present study, the authors have tried open-flap debridement (OFD) of mandibular molars with Class II furcation involvement followed by placement of a combination of 1.2 mg RSV in situ gel with a 1:1 mixture of autologous PRF and porous HA bone graft.
