Does the association of blood-derived growth factors to nanostructured carbonated hydroxyapatite contributes to the maxillary sinus floor elevation? A randomized clinical trial
- 158 Downloads
The combination of calcium phosphate with blood-derived growth factors (BDGF) has been widely used in bone regeneration procedures although its benefits are still unclear. The purpose of this study was to evaluate whether or not BDGF improves the efficacy of a modified carbonated calcium phosphate biomaterial in sinus floor augmentation.
Material and methods
Ten patients underwent 20 sinus floor augmentation procedures using nanostructured carbonated hydroxyapatite (cHA) microspheres alone or associated with BDGF in a randomized controlled clinical trial. The in vitro release of growth factors was assessed by an elution assay. Bone grafts were randomly implanted in the right and left maxillary sinuses of each participant, associated either with a 0.9% saline solution or BDGF. Bone gain was evaluated through cone beam tomography after 180 days.
Nine women and one man composed the sample. The blood-derived concentrates were able to release high levels of growth factors and cytokines. A significant clinical advantage was observed in the use of the BDGF after fibrin polymerization around the biomaterial microspheres, optimizing the surgical procedures, thereby reducing the time and displacement, and improving the adaptation of the biomaterial in the maxillary sinus. No synergistic effect was observed in bone formation when cHA was associated with BDGF (p > 0.05).
Equivalent new bone formation was observed for cHA in the presence or absence of the BDGF concentrate in bilateral sinus floor elevation after 6 months. Blood-derived growth factors did not improve bone repair when associated with calcium phosphate in sinus lift procedures.
KeywordsClinical trials Growth factors Biomaterials Sinus floor elevation
Authors thank the Laboratório Nacional de Luz Síncrotron for the physicochemical evaluation of the biomaterials.
This study if financially supported by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES), Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ), process no. E-26/110.303/2014, and Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq). INCT-REGENERA/CNPQ/FAPERJ.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/ national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical Standards (CONEP, Brazil no. 1.345.263).
Informed consent was obtained from all individual participants included in the study.
- 1.Becktor JP, Isaksson S, Sennerby L (2007) Endosseous implants and bone augmentation in the partially dentate maxilla: an analysis of 17 patients with a follow-up of 29 to 101 months. Int J Oral Maxillofac Implants 22:603–608Google Scholar
- 2.Toljanic J, Baer R, Ekstrand KTA (2009) Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial. Int J Oral Maxillofac Implant 24:518–526Google Scholar
- 4.Testori T, Wallace SS, Trisi P, Capelli M, Zuffetti F, del Fabbro M (2013) Effect of xenograft (ABBM) particle size on vital bone formation following maxillary sinus augmentation: a multicenter, randomized, controlled, clinical histomorphometric trial. Int J Periodontics Restor Dent 33:467–475. https://doi.org/10.11607/prd.1423 CrossRefGoogle Scholar
- 6.Fugazzotto PA, Vlassis J (1998) Long-term success of sinus augmentation using various surgical approaches and grafting materials. Int J Oral Maxillofac Implant 13:52–58Google Scholar
- 9.Chiapasco M, Casentini P, Zaniboni M (2009) Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants 24(Suppl):237–259Google Scholar
- 11.Tatum OH Jr (1977) Maxillary sinus grafting for endosseous implants. Presented at the Annual Meeting of the Alabama Implant Study Group, Birmingham, ALGoogle Scholar
- 12.Boyne PJ, James RA (1980) Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg 38(8):613–616Google Scholar
- 13.Wood RM, Moore DL (1988) Grafting of the maxillary sinus with intraorally harvested autogenous bone prior to implant placement. Int J Oral Maxillofac Implants 3:209-214Google Scholar
- 16.Kang T (2008) Sinus elevation using a staged osteotome technique for site development prior to implant placement in sites with less than 5 mm of native bone: a case report. Int J Periodontics Restorative Dent 28:73–81Google Scholar
- 17.Klijn RJ, Meijer GJ, Bronkhorst EM, Jansen JA (2010) A meta-analysis of histomorphometric results and graft healing time of various biomaterials compared to autologous bone used as sinus floor augmentation material in humans. Tissue Eng Part B Rev 16:493–507Google Scholar
- 19.Schmitt CM, Moest T, Lutz R, Neukam FW, Schlegel KA (2015) Anorganic bovine bone (ABB) vs. autologous bone (AB) plus ABB in maxillary sinus grafting. A prospective non-randomized clinical and histomorphometrical trial. Clin Oral Implants Res 26:1043–1050. https://doi.org/10.1111/clr.12396 CrossRefGoogle Scholar
- 21.Babbush C (1998) Sinus lift revisited: an update on current implant-related procedures. Sinus lift revisited: an update on current implant-related procedures. Dent Implant Updat 9:1–5Google Scholar
- 24.Dohle E, El Bagdadi K, Sader R, Choukroun J, James Kirkpatrick CGS (2017) PRF-based matrices to improve angiogenesis in an in vitro co-culture model for bone tissue engineering. J Tissue Eng Regen Med 16Google Scholar
- 25.Marx RE, Carlson ER, Eichstaedt RM, Schimmele SR, Strauss JE, Georgeff KR (1998) Platelet-rich plasma: growth factor enhancement for bone grafts. Oral Surg, Oral Med, Oral Pathol, Oral Radiol, Endod 85(6):638–646Google Scholar
- 26.Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJJ, Mouhyi J, Gogly B (2006) Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral surgery, oral med oral Pathol oral Radiol. Endodontology 101:45–50. https://doi.org/10.1016/j.tripleo.2005.07.008 Google Scholar
- 27.Dohan Ehrenfest DM, Pinto NR, Pereda A, Jiménez P, Corso MD, Kang BS, Nally M, Lanata N, Wang HL, Quirynen M (2017) The impact of the centrifuge characteristics and centrifugation protocols on the cells, growth factors, and fibrin architecture of a leukocyte- and platelet-rich fibrin (L-PRF) clot and membrane. Platelets 24:1–14. https://doi.org/10.1080/09537104.2017.1293812 Google Scholar
- 29.Miron R, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati SCJ (2017) Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig 2Google Scholar
- 30.Schulz KF, Altman DG, Moher D (2010) CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 340:c332Google Scholar
- 31.Carl E. Misch (2008) Contemporary Implant Dent, 3 Ed.Google Scholar
- 33.Gassling V, Purcz N, Braesen JH, Will M, Gierloff M, Behrens E, Açil Y, Wiltfang J (2013) Comparison of two different absorbable membranes for the coverage of lateral osteotomy sites in maxillary sinus augmentation: a preliminary study. J Cranio-Maxillofacial Surg 41:76–82. https://doi.org/10.1016/j.jcms.2012.10.015 CrossRefGoogle Scholar
- 34.Calasans-Maia M, Resende R, Fernandes G, Calasans-Maia J, Alves AT, Granjeiro JM (2014) A randomized controlled clinical trial to evaluate a new xenograft for alveolar socket preservation. Clin Oral Impl Res 25:1125–1130Google Scholar
- 37.Mertens C, Meyer-Bäumer A, Kappel H, Hoffmann J, Steveling HG (2012) Use of 8-mm and 9-mm implants in atrophic alveolar ridges: 10-year results. Int J Oral Maxillofac Implants 27:1501–1508Google Scholar
- 38.Taschieri S, Testori T, Corbella S et al (2015) Platelet-rich plasma and deproteinized bovine bone matrix in maxillary sinus lift surgery: a split-mouth histomorphometric evaluation. Implant Dent. https://doi.org/10.1097/ID.0000000000000293
- 39.Moraschini V, Uzeda MG, Sartoretto SC, Calasans-Maia (2017) Maxillary sinus floor elevation with simultaneous implant placement without grafting materials: a systematic review and meta-analysis. Int J Oral Maxillofac Surg 46(5):636-647. https://doi.org/10.1016/j.ijom.2017.01.021
- 40.Mazor Z, Horowitz RA, Del Corso M et al (2009) Sinus floor augmentation with simultaneous implant placement using Choukroun’s platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol 80:2056–2064. https://doi.org/10.1902/jop.2009.090252 CrossRefGoogle Scholar
- 44.Anitua E (1999) Plasma rich in growth factors: preliminary results of use in the preparation of future sites for implants. Int J Oral Maxillofac Implants 14:529–535Google Scholar
- 45.Pocaterra A, Caruso S, Bernardi S, Scagnoli L, Continenza MA, Gatto R (2016) Effectiveness of platelet-rich plasma as an adjunctive material to bone graft: a systematic review and meta-analysis of randomized controlled clinical trials. Int J Oral Maxillofac Surg 45:1027–1034. https://doi.org/10.1016/j.ijom.2016.02.012 CrossRefGoogle Scholar