Factors Influencing Bone Block Allograft Resorption

Graft Loss Clinical Trial

Official title:

Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412838
• Other study ID #: P-15/566
• Status: Completed
• Phase: N/A
• First received: January 14, 2018
• Last updated: January 19, 2018
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2018
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.

Description:

Introduction: A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.

Materials and methods: Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. The aforementioned groups were compared in regards to bone resorption using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site were also analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Twenty eight totally and partially edentulous patients referred for dental implant therapy from January 2011 to September 2015 were enrolled in the study. All patients had insufficient bucco-lingual (BL) alveolar bone width (<4 mm) that prevented placement of regular size implants

Exclusion Criteria:

• Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study. In addition, patients who were pregnant, or patients with diseases affecting bone, such as Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

Related Conditions & MeSH terms

• Graft Loss

Intervention

Procedure:
• graft surgery
A graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

References & Publications (52)

Acocella A, Bertolai R, Ellis E 3rd, Nissan J, Sacco R. Maxillary alveolar ridge reconstruction with monocortical fresh-frozen bone blocks: a clinical, histological and histomorphometric study. J Craniomaxillofac Surg. 2012 Sep;40(6):525-33. doi: 10.1016/j.jcms.2011.09.004. Epub 2011 Nov 9. — View Citation

Al-Abedalla K, Torres J, Cortes AR, Wu X, Nader SA, Daniel N, Tamimi F. Bone Augmented With Allograft Onlays for Implant Placement Could Be Comparable With Native Bone. J Oral Maxillofac Surg. 2015 Nov;73(11):2108-22. doi: 10.1016/j.joms.2015.06.151. Epub 2015 Jun 20. — View Citation

Alleyne B, Varghai D, Askeroglu U, Zwiebel S, Tobin K, Gosain AK. The Impact of Age Upon Healing: Absolute Quantification of Osteogenic Genes in Calvarial Critical-Sized Defects. J Craniofac Surg. 2016 Jan;27(1):258-63. doi: 10.1097/SCS.0000000000001313. — View Citation

Alonso N, Machado de Almeida O, Jorgetti V, Amarante MT. Cranial versus iliac onlay bone grafts in the facial skeleton: a macroscopic and histomorphometric study. J Craniofac Surg. 1995 Mar;6(2):113-8; discussion 119. — View Citation

Anitua E. Plasma rich in growth factors: preliminary results of use in the preparation of future sites for implants. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):529-35. — View Citation

Barone A, Varanini P, Orlando B, Tonelli P, Covani U. Deep-frozen allogeneic onlay bone grafts for reconstruction of atrophic maxillary alveolar ridges: a preliminary study. J Oral Maxillofac Surg. 2009 Jun;67(6):1300-6. doi: 10.1016/j.joms.2008.12.043. — View Citation

Belser UC, Schmid B, Higginbottom F, Buser D. Outcome analysis of implant restorations located in the anterior maxilla: a review of the recent literature. Int J Oral Maxillofac Implants. 2004;19 Suppl:30-42. Review. — View Citation

Bouletreau PJ, Warren SM, Spector JA, Peled ZM, Gerrets RP, Greenwald JA, Longaker MT. Hypoxia and VEGF up-regulate BMP-2 mRNA and protein expression in microvascular endothelial cells: implications for fracture healing. Plast Reconstr Surg. 2002 Jun;109(7):2384-97. — View Citation

Buffoli B, Boninsegna R, Rezzani R, Poli PP, Santoro F, Rodella LF. Histomorphometrical evaluation of fresh frozen bone allografts for alveolar bone reconstruction: preliminary cases comparing femoral head with iliac crest grafts. Clin Implant Dent Relat Res. 2013 Dec;15(6):791-8. doi: 10.1111/cid.12028. Epub 2013 Jan 7. — View Citation

Carinci F, Brunelli G, Franco M, Viscioni A, Rigo L, Guidi R, Strohmenger L. A retrospective study on 287 implants installed in resorbed maxillae grafted with fresh frozen allogenous bone. Clin Implant Dent Relat Res. 2010 Jun 1;12(2):91-8. doi: 10.1111/j.1708-8208.2008.00133.x. Epub 2008 Dec 3. — View Citation

Chaushu G, Mardinger O, Peleg M, Ghelfan O, Nissan J. Analysis of complications following augmentation with cancellous block allografts. J Periodontol. 2010 Dec;81(12):1759-64. doi: 10.1902/jop.2010.100235. Epub 2010 Aug 3. — View Citation

Chiapasco M, Autelitano L, Rabbiosi D, Zaniboni M. The role of pericranium grafts in the reduction of postoperative dehiscences and bone resorption after reconstruction of severely deficient edentulous ridges with autogenous onlay bone grafts. Clin Oral Implants Res. 2013 Jun;24(6):679-87. doi: 10.1111/j.1600-0501.2012.02485.x. Epub 2012 May 3. — View Citation

Chiapasco M, Colletti G, Coggiola A, Di Martino G, Anello T, Romeo E. Clinical outcome of the use of fresh frozen allogeneic bone grafts for the reconstruction of severely resorbed alveolar ridges: preliminary results of a prospective study. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):450-60. doi: 10.11607/jomi.3763. — View Citation

Chiapasco M, Di Martino G, Anello T, Zaniboni M, Romeo E. Fresh frozen versus autogenous iliac bone for the rehabilitation of the extremely atrophic maxilla with onlay grafts and endosseous implants: preliminary results of a prospective comparative study. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e251-66. doi: 10.1111/cid.12191. Epub 2013 Dec 27. — View Citation

Contar CM, Sarot JR, Bordini J Jr, Galvão GH, Nicolau GV, Machado MA. Maxillary ridge augmentation with fresh-frozen bone allografts. J Oral Maxillofac Surg. 2009 Jun;67(6):1280-5. doi: 10.1016/j.joms.2008.11.010. — View Citation

Donovan MG, Dickerson NC, Hellstein JW, Hanson LJ. Autologous calvarial and iliac onlay bone grafts in miniature swine. J Oral Maxillofac Surg. 1993 Aug;51(8):898-903. — View Citation

Ehrler DM, Vaccaro AR. The use of allograft bone in lumbar spine surgery. Clin Orthop Relat Res. 2000 Feb;(371):38-45. Review. — View Citation

Esposito M, Hirsch JM, Lekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (I). Success criteria and epidemiology. Eur J Oral Sci. 1998 Feb;106(1):527-51. — View Citation

Föger-Samwald U, Patsch JM, Schamall D, Alaghebandan A, Deutschmann J, Salem S, Mousavi M, Pietschmann P. Molecular evidence of osteoblast dysfunction in elderly men with osteoporotic hip fractures. Exp Gerontol. 2014 Sep;57:114-21. doi: 10.1016/j.exger.2014.05.014. Epub 2014 May 24. — View Citation

Föger-Samwald U, Vekszler G, Hörz-Schuch E, Salem S, Wipperich M, Ritschl P, Mousavi M, Pietschmann P. Molecular mechanisms of osteoporotic hip fractures in elderly women. Exp Gerontol. 2016 Jan;73:49-58. doi: 10.1016/j.exger.2015.11.012. Epub 2015 Dec 1. — View Citation

Fu JH, Wang HL. Horizontal bone augmentation: the decision tree. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):429-36. — View Citation

Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9. — View Citation

Haddad FS, Spangehl MJ, Masri BA, Garbuz DS, Duncan CP. Circumferential allograft replacement of the proximal femur. A critical analysis. Clin Orthop Relat Res. 2000 Feb;(371):98-107. — View Citation

Hardesty RA, Marsh JL. Craniofacial onlay bone grafting: a prospective evaluation of graft morphology, orientation, and embryonic origin. Plast Reconstr Surg. 1990 Jan;85(1):5-14; discussion 15. — View Citation

He YX, Zhang G, Pan XH, Liu Z, Zheng LZ, Chan CW, Lee KM, Cao YP, Li G, Wei L, Hung LK, Leung KS, Qin L. Impaired bone healing pattern in mice with ovariectomy-induced osteoporosis: A drill-hole defect model. Bone. 2011 Jun 1;48(6):1388-400. doi: 10.1016/j.bone.2011.03.720. Epub 2011 Mar 21. — View Citation

Ishida K, Matsumoto T, Sasaki K, Mifune Y, Tei K, Kubo S, Matsushita T, Takayama K, Akisue T, Tabata Y, Kurosaka M, Kuroda R. Bone regeneration properties of granulocyte colony-stimulating factor via neovascularization and osteogenesis. Tissue Eng Part A. 2010 Oct;16(10):3271-84. doi: 10.1089/ten.tea.2009.0268. — View Citation

Jaffin RA, Berman CL. The excessive loss of Branemark fixtures in type IV bone: a 5-year analysis. J Periodontol. 1991 Jan;62(1):2-4. — View Citation

Keith JD Jr, Petrungaro P, Leonetti JA, Elwell CW, Zeren KJ, Caputo C, Nikitakis NG, Schöpf C, Warner MM. Clinical and histologic evaluation of a mineralized block allograft: results from the developmental period (2001-2004). Int J Periodontics Restorative Dent. 2006 Aug;26(4):321-7. — View Citation

Levin L, Kessler-Baruch O. Cigarette smoking and the alveolar bone around teeth and dental implants. N Y State Dent J. 2013 Aug-Sep;79(5):53-9. Review. — View Citation

Lumetti S, Consolo U, Galli C, Multinu A, Piersanti L, Bellini P, Manfredi E, Corinaldesi G, Zaffe D, Macaluso GM, Marchetti C. Fresh-frozen bone blocks for horizontal ridge augmentation in the upper maxilla: 6-month outcomes of a randomized controlled trial. Clin Implant Dent Relat Res. 2014 Feb;16(1):116-23. doi: 10.1111/j.1708-8208.2012.00458.x. Epub 2012 Apr 24. — View Citation

Lumetti S, Galli C, Manfredi E, Consolo U, Marchetti C, Ghiacci G, Toffoli A, Bonanini M, Salgarelli A, Macaluso GM. Correlation between density and resorption of fresh-frozen and autogenous bone grafts. Biomed Res Int. 2014;2014:508328. doi: 10.1155/2014/508328. Epub 2014 Jun 24. — View Citation

Lundgren S, Sjöström M, Nyström E, Sennerby L. Strategies in reconstruction of the atrophic maxilla with autogenous bone grafts and endosseous implants. Periodontol 2000. 2008;47:143-61. doi: 10.1111/j.1600-0757.2008.00265.x. — View Citation

McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. Review. — View Citation

Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76. — View Citation

Nahles S, Nack C, Gratecap K, Lage H, Nelson JJ, Nelson K. Bone physiology in human grafted and non-grafted extraction sockets--an immunohistochemical study. Clin Oral Implants Res. 2013 Jul;24(7):812-9. doi: 10.1111/j.1600-0501.2012.02462.x. Epub 2012 Mar 30. — View Citation

Nevins M, Mellonig JT. The advantages of localized ridge augmentation prior to implant placement: a staged event. Int J Periodontics Restorative Dent. 1994 Apr;14(2):96-111. — View Citation

Nissan J, Ghelfan O, Mardinger O, Calderon S, Chaushu G. Efficacy of cancellous block allograft augmentation prior to implant placement in the posterior atrophic mandible. Clin Implant Dent Relat Res. 2011 Dec;13(4):279-85. doi: 10.1111/j.1708-8208.2009.00219.x. Epub 2009 Aug 5. — View Citation

Nissan J, Mardinger O, Calderon S, Romanos GE, Chaushu G. Cancellous bone block allografts for the augmentation of the anterior atrophic maxilla. Clin Implant Dent Relat Res. 2011 Jun;13(2):104-11. doi: 10.1111/j.1708-8208.2009.00193.x. — View Citation

Nissan J, Marilena V, Gross O, Mardinger O, Chaushu G. Histomorphometric analysis following augmentation of the anterior atrophic maxilla with cancellous bone block allograft. Int J Oral Maxillofac Implants. 2012 Jan-Feb;27(1):84-9. — View Citation

Nissan J, Marilena V, Gross O, Mardinger O, Chaushu G. Histomorphometric analysis following augmentation of the posterior mandible using cancellous bone-block allograft. J Biomed Mater Res A. 2011 Jun 15;97(4):509-13. doi: 10.1002/jbm.a.33096. Epub 2011 Apr 20. — View Citation

Norton MR, Gamble C. Bone classification: an objective scale of bone density using the computerized tomography scan. Clin Oral Implants Res. 2001 Feb;12(1):79-84. — View Citation

Ozaki W, Buchman SR, Goldstein SA, Fyhrie DP. A comparative analysis of the microarchitecture of cortical membranous and cortical endochondral onlay bone grafts in the craniofacial skeleton. Plast Reconstr Surg. 1999 Jul;104(1):139-47. — View Citation

Ozaki W, Buchman SR. Volume maintenance of onlay bone grafts in the craniofacial skeleton: micro-architecture versus embryologic origin. Plast Reconstr Surg. 1998 Aug;102(2):291-9. — View Citation

Peleg M, Sawatari Y, Marx RN, Santoro J, Cohen J, Bejarano P, Malinin T. Use of corticocancellous allogeneic bone blocks for augmentation of alveolar bone defects. Int J Oral Maxillofac Implants. 2010 Jan-Feb;25(1):153-62. — View Citation

Spin-Neto R, Landazuri Del Barrio RA, Pereira LA, Marcantonio RA, Marcantonio E, Marcantonio E Jr. Clinical similarities and histological diversity comparing fresh frozen onlay bone blocks allografts and autografts in human maxillary reconstruction. Clin Implant Dent Relat Res. 2013 Aug;15(4):490-7. doi: 10.1111/j.1708-8208.2011.00382.x. Epub 2011 Aug 11. — View Citation

Spin-Neto R, Stavropoulos A, Coletti FL, Faeda RS, Pereira LA, Marcantonio E Jr. Graft incorporation and implant osseointegration following the use of autologous and fresh-frozen allogeneic block bone grafts for lateral ridge augmentation. Clin Oral Implants Res. 2014 Feb;25(2):226-33. doi: 10.1111/clr.12107. Epub 2013 Jan 25. — View Citation

Torres J, Tamimi F, Alkhraisat MH, Manchón A, Linares R, Prados-Frutos JC, Hernández G, López Cabarcos E. Platelet-rich plasma may prevent titanium-mesh exposure in alveolar ridge augmentation with anorganic bovine bone. J Clin Periodontol. 2010 Oct;37(10):943-51. doi: 10.1111/j.1600-051X.2010.01615.x. — View Citation

Torres J, Tamimi F, Martinez PP, Alkhraisat MH, Linares R, Hernández G, Torres-Macho J, López-Cabarcos E. Effect of platelet-rich plasma on sinus lifting: a randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):677-87. doi: 10.1111/j.1600-051X.2009.01437.x. Epub 2009 Jun 26. — View Citation

Viscioni A, Franco M, Rigo L, Guidi R, Spinelli G, Carinci F. Retrospective study of standard-diameter implants inserted into allografts. J Oral Maxillofac Surg. 2009 Feb;67(2):387-93. doi: 10.1016/j.joms.2008.06.099. — View Citation

Waasdorp J, Reynolds MA. Allogeneic bone onlay grafts for alveolar ridge augmentation: a systematic review. Int J Oral Maxillofac Implants. 2010 May-Jun;25(3):525-31. Review. — View Citation

Zins JE, Whitaker LA. Membranous versus endochondral bone: implications for craniofacial reconstruction. Plast Reconstr Surg. 1983 Dec;72(6):778-85. — View Citation

Zmolek JC, Dorr LD. Revision total hip arthroplasty. The use of solid allograft. J Arthroplasty. 1993 Aug;8(4):361-70. — View Citation

* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Bone Augmentation	A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.	0 months
Secondary	Percentage of bone resorption	A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.	4 months