Factors Influencing Bone Block Allograft Resorption
Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Cortico-Cancellous
Graft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
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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
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アクティブコンパレータ:Cancellous
Graft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
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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
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Bone Augmentation
時間枠:0 months
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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.
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0 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of bone resorption
時間枠:4 months
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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.
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4 months
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協力者と研究者
捜査官
- 主任研究者:Jesus Torres、Universidad Complutense de Madrid
出版物と役立つリンク
一般刊行物
- Ehrler DM, Vaccaro AR. The use of allograft bone in lumbar spine surgery. Clin Orthop Relat Res. 2000 Feb;(371):38-45. doi: 10.1097/00003086-200002000-00005.
- Fu JH, Wang HL. Horizontal bone augmentation: the decision tree. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):429-36.
- 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.
- McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lundgren S, Sjostrom M, Nystrom 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. No abstract available.
- Zmolek JC, Dorr LD. Revision total hip arthroplasty. The use of solid allograft. J Arthroplasty. 1993 Aug;8(4):361-70. doi: 10.1016/s0883-5403(06)80034-3.
- 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. doi: 10.1097/00003086-200002000-00011.
- 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.
- 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.
- 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.
- 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.
- Contar CM, Sarot JR, Bordini J Jr, Galvao 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1016/s0278-2391(10)80112-0.
- 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. doi: 10.1097/00001665-199503000-00006.
- Zins JE, Whitaker LA. Membranous versus endochondral bone: implications for craniofacial reconstruction. Plast Reconstr Surg. 1983 Dec;72(6):778-85. doi: 10.1097/00006534-198312000-00005.
- 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.
- 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. doi: 10.1097/00006534-199808000-00001.
- 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.
- 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.
- Keith JD Jr, Petrungaro P, Leonetti JA, Elwell CW, Zeren KJ, Caputo C, Nikitakis NG, Schopf 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.
- 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.
- 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.
- 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. doi: 10.1034/j.1600-0501.2001.012001079.x.
- 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. doi: 10.1902/jop.1991.62.1.2.
- 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. doi: 10.1046/j.0909-8836..t01-2-.x.
- Foger-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.
- Foger-Samwald U, Vekszler G, Horz-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.
- 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.
- Torres J, Tamimi F, Martinez PP, Alkhraisat MH, Linares R, Hernandez G, Torres-Macho J, Lopez-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.
- 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.
- Torres J, Tamimi F, Alkhraisat MH, Manchon A, Linares R, Prados-Frutos JC, Hernandez G, Lopez 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.
- 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. doi: 10.1097/00006534-200206000-00033.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
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学習記録の更新
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QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- P-15/566
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個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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graft surgeryの臨床試験
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Bournemouth UniversityStryker Orthopaedics; Nuffield Health Bournemouth; Orthopaedic Research Institute募集
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University Hospital of Cologneわからない歯槽骨の高さが不十分な後上顎の無歯顎患者
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Dr. Sabrina Overhagen積極的、募集していない