The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in a human clinical trial

Biomaterials

Volumn 28, Issue 22, 2007, Pages 3295-3305

  Weiss, Pierre ^a,b,c   Layrolle, Pierre ^a,b   Clergeau, Léon Philippe ^b,c   Enckel, Bénédicte ^b,c   Pilet, Paul ^a,c   Amouriq, Yves ^b,c   Daculsi, Guy ^a,b   Giumelli, Bernard ^b,c  

^a Universite de Nantes   (France)

^b UNIVERSITÉ DE NANTES   (France)

^c NANTES UNIVERSITY HOSPITAL   (France)

Author keywords

Biomaterial; Bone healing; Calcium phosphate; Human trial; Injectable bone substitute

Indexed keywords

BONE; CALCIUM PHOSPHATE; COMPUTERIZED TOMOGRAPHY; PATIENT TREATMENT; RADIOGRAPHY;

BIPHASIC CALCIUM PHOSPHATE (BCP); BONE HEALING; HUMAN TRIAL; INJECTABLE BONE SUBSTITUTE (IBS);

DENTAL PROSTHESES;

BIOMATERIAL; CALCIUM PHOSPHATE; CELLULOSE; FILLER;

ADULT; ARTICLE; BIOPSY; BONE ATROPHY; BONE DEFECT; BONE GROWTH; BONE MINERALIZATION; BONE PROSTHESIS; BONE RADIOGRAPHY; BONE TISSUE; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; FEMALE; HISTOLOGY; HUMAN; HUMAN TISSUE; IMPLANT; MALE; MICRO-COMPUTED TOMOGRAPHY; MORPHOMETRICS; OSTEOLYSIS; PARTICLE SIZE; PATIENT SAFETY; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; SUSPENSION; TOOTH EXTRACTION; TOOTH FILLING; TOOTH SOCKET;

ADULT; BIOCOMPATIBLE MATERIALS; BONE AND BONES; BONE RESORPTION; BONE SUBSTITUTES; CALCIUM PHOSPHATES; CELLULOSE; DENTAL IMPLANTATION, ENDOSSEOUS; DENTAL IMPLANTS; DRUG CARRIERS; FEMALE; HUMANS; MALE; MANDIBLE; OSSEOINTEGRATION; TOOTH SOCKET;

EID: 34248149045     PISSN: 01429612     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biomaterials.2007.04.006     Document Type: Article

References (48)

1. De groot K. Bioceramics consisting of calcium phosphate salts. Biomaterials 1 (1980) 47-50
2. Daculsi G., LeGeros R.Z., Heughebaert M., and Barbieux I. Formation of carbonate-apatite crystals after implantation of calcium phosphate ceramics. Calcif Tissue Int 46 1 (1990) 20-27
3. Passuti N., Daculsi G., Rogez J.M., Martin S., and Bainvel J.V. Macroporous calcium phosphate ceramic performance in human spine fusion. Clin Orthop 248 (1989) 169-176
4. Cavagna R., Daculsi G., and Bouler J.M. Macroporous calcium phosphate ceramic: a prospective study of 106 cases in lumbar spinal fusion. J Long Term Eff Med Implants 9 4 (1999) 403-412
5. LeGeros R.Z. Calcium phosphate materials in restorative dentistry: a review. Adv Dent Res 2 1 (1988) 164-180
6. Delecrin J., Daculsi G., Passuti N., and duquet B. Specific resorbable calcium phosphate coating to enhance osteoconduction. Cells Mater 4 (1994) 51-62
7. Daculsi G., LeGeros R., Nery E., Lynch K., and Kerebel B. Transformation of biophasic calcium phosphate ceramics in vivo: ultrastructural and physicochemical characterization. J Biomed Mater Res 23 (1989) 883-894
8. Daculsi G., LeGeros R.Z., and Deudon C. Scanning and transmission electron microscopy, and electron probe analysis of the interface between implants and host bone. Osseo- coalescence versus osseo-integration. Scann Microsc 4 2 (1990) 309-314
9. Verlaan J.J., Oner F.C., and Dhert W.J. Anterior spinal column augmentation with injectable bone cements. Biomaterials 27 3 (2006) 290-301
10. Taylor R.S., Fritzell P., and Taylor R.J. Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis. Eur Spine J (2007)
11. Malawer M.M., and Dunham W. Cryosurgery and acrylic cementation as surgical adjuncts in the treatment of aggressive (benign) bone tumors. Analysis of 25 patients below the age of 21. Clin Orthopaed Relat Res 262 (1991) 42-57
12. Drissens F., Bolton M., Bermudez O., Planell J., Ginebra M., and Fernandez E. Effective formulatiom for the preparation of calcium phosphate hone cements. J Mater Sci 5 (1994) 164-170
13. Takechi M., Miyamoto Y., Ishikawa K., Nagayama M., Kon M., Asaoka K., et al. Effects of added antibiotics on the basic properties of anti-washout-type fast-setting calcium phosphate cement. J Biomed Mater Res 39 2 (1998) 308-316
14. Carey L.E., Xu H.H., Simon Jr. C.G., Takagi S., and Chow L.C. Premixed rapid-setting calcium phosphate composites for bone repair. Biomaterials 26 24 (2005) 5002-5014
15. Constantz B., Ison I., Fulmer M., Poser R., Smith S., VanWagoner M., et al. Skeletal repair by in situ formation of the mineral phase of bone. Science 267 (1995) 1796-1799
16. Daculsi G., and Passuti N. Effect of the macroporosity for osseous substitution of calcium phosphate ceramics. Biomaterials 11 (1990) 86-87
17. Daculsi G, Weiss P, Delecrin J, Grimandi G, Passuti N, inventors. CNRS patent: biomaterial composition-preparation proceeding, France, 1994 8/2/94.
18. Gauthier O., Bouler J.M., Weiss P., Bosco J., Daculsi G., and Aguado E. Kinetic study of bone ingrowth and ceramic resorption associated with the implantation of different injectable calcium-phosphate bone substitutes. J Biomed Mater Res 47 1 (1999) 28-35
19. Weiss P., Gauthier O., Bouler J.M., Grimandi G., and Daculsi G. Injectable bone substitute using a hydrophilic polymer. Bone 25 2 Suppl (1999) 67S-70S
20. ®) of an injectable bone substitute in guinea pigs. J Mater Sci Mater Med 13 2 (2002) 149-154
21. Daculsi G., Laboux O., Malard O., and Weiss P. Current state of the art of biphasic calcium phosphate bioceramics. J Mater Sci Mater Med 14 3 (2003) 195-200
22. Daculsi G. Biphasic calcium phosphate concept applied to artificial bone, implant coating and injectable bone substitute. Biomaterials 19 16 (1998) 1473-1478
23. Gordon P.D. The Rinn XCP system. Dent Update 1 7 (1974) 373-374 6-7
24. Boix D., Gauthier O., Guicheux J., Pilet P., Weiss P., Grimandi G., et al. Alveolar bone regeneration for immediate implant placement using an injectable bone substitute: an experimental study in dogs. J Periodontol 75 5 (2004) 663-671
25. Boix D., Weiss P., Gauthier O., Guicheux J., Bouler J.M., Pilet P., et al. Injectable bone substitute to preserve alveolar ridge resorption after tooth extraction: a study in dog. J Mater Sci Mater Med 17 11 (2006) 1145-1152
26. Temenoff J.S., and Mikos A.G. Injectable biodegradable materials for orthopedic tissue engineering. Biomaterials 21 23 (2000) 2405-2412 2000/12/1
27. Lewandrowski K.-U., Gresser J.D., Wise D.L., White R.L., and Trantolo D.J. Osteoconductivity of an injectable and bioresorbable poly(propylene glycol-co-fumaric acid) bone cement. Biomaterials 21 3 (2000) 293-298 2000/2
28. Li Y.W., Leong J.C., Lu W.W., Luk K.D., Cheung K.M., Chiu K.Y., et al. A novel injectable bioactive bone cement for spinal surgery: a developmental and preclinical study. J Biomed Mater Res 52 1 (2000) 164-170
29. Aho A.J., Tirri T., Kukkonen J., Strandberg N., Rich J., Seppala J., et al. Injectable bioactive glass/biodegradable polymer composite for bone and cartilage reconstruction: concept and experimental outcome with thermoplastic composites of poly(epsilon-caprolactone-co-d,l-lactide) and bioactive glass S53P4. J Mater Sci Mater Med 15 10 (2004) 1165-1173
30. Weiss P., Obadia L., Magne D., Bourges X., Rau C., Weitkamp T., et al. Synchrotron X-ray microtomography (on a micron scale) provides three-dimensional imaging representation of bone ingrowth in calcium phosphate biomaterials. Biomaterials 24 25 (2003) 4591-4601
31. Gauthier O., Khairoun I., Bosco J., Obadia L., Bourges X., Rau C., et al. Noninvasive bone replacement with a new injectable calcium phosphate biomaterial. J Biomed Mater Res 66A 1 (2003) 47-54
32. Moghadam H.G., Sandor G.K., Holmes H.H., and Clokie C.M. Histomorphometric evaluation of bone regeneration using allogeneic and alloplastic bone substitutes. J Oral Maxillofac Surg 62 2 (2004) 202-213
33. Wolff K.D., Swaid S., Nolte D., Bockmann R.A., Holzle F., and Muller-Mai C. Degradable injectable bone cement in maxillofacial surgery: indications and clinical experience in 27 patients. J Craniomaxillofac Surg 32 2 (2004) 71-79
34. Horstmann W.G., Verheyen C.C., and Leemans R. An injectable calcium phosphate cement as a bone-graft substitute in the treatment of displaced lateral tibial plateau fractures. Injury 34 2 (2003) 141-144
35. Shanaman R., Filstein M.R., and Danesh-Meyer M.J. Localized ridge augmentation using GBR and platelet-rich plasma: case reports. Int J Periodontics Restorative Dent 21 4 (2001) 345-355
36. Grimandi G., Weiss P., Millot F., and Daculsi G. In vitro evaluation of a new injectable calcium phosphate material. J Biomed Mater Res 39 4 (1998) 660-666
37. Gauthier O., Muller R., von Stechow D., Lamy B., Weiss P., Bouler J.-M., et al. In vivo bone regeneration with injectable calcium phosphate biomaterial: a three-dimensional micro-computed tomographic, biomechanical and SEM study. Biomaterials 26 27 (2005) 5444-5453 2005/9
38. Gauthier O., Boix D., Grimandi G., Aguado E., Bouler J.M., Weiss P., et al. A new injectable calcium phosphate biomaterial for immediate bone filling of extraction sockets: a preliminary study in dogs. J Periodontol 70 4 (1999) 375-383
39. Thorwarth M., Schultze-Mosgau S., Kessler P., Wiltfang J., and Schlegel K.A. Bone regeneration in osseous defects using a resorbable nanoparticular hydroxyapatite. J Oral Maxillofac Surg 63 11 (2005) 1626-1633
40. Malard O., Bouler J.M., Guicheux J., Heymann D., Pilet P., Coquard C., et al. Influence of biphasic calcium phosphate granulometry on bone ingrowth, ceramic resorption, and inflammatory reactions: preliminary in vitro and in vivo study. J Biomed Mater Res 46 1 (1999) 103-111
41. Nguyen H., Qian J.J., Bhatnagar R.S., and Li S. Enhanced cell attachment and osteoblastic activity by P-15 peptide-coated matrix in hydrogels. Biochem Biophys Res Commun 311 1 (2003) 179-186
42. Merkx M.A., Maltha J.C., and Stoelinga P.J. Assessment of the value of anorganic bone additives in sinus floor augmentation: a review of clinical reports. Int J Oral Maxillofac Surg 32 1 (2003) 1-6
43. Gaasbeek R.D., Toonen H.G., van Heerwaarden R.J., and Buma P. Mechanism of bone incorporation of beta-TCP bone substitute in open wedge tibial osteotomy in patients. Biomaterials 26 33 (2005) 6713-6719
44. van Hemert W., Willems K., Anderson G., van Heerwaarden R., and Wymenga A.B. Tricalcium phosphate granules or rigid wedge preforms in open wedge high tibial osteotomy: a radiological study with a new evaluation system. Knee 11 (2004) 451-456
45. Zerbo I.R., Bronckers A.L., de Lange G., and Burger E.H. Localisation of osteogenic and osteoclastic cells in porous beta-tricalcium phosphate particles used for human maxillary sinus floor elevation. Biomaterials 26 12 (2005) 1445-1451
46. Paolantonio M., Scarano A., Di Placido G., Tumini V., D'Archivio D., and Piattelli A. Periodontal healing in humans using anorganic bovine bone and bovine peritoneum-derived collagen membrane: a clinical and histologic case report. Int J Periodontics Restorative Dent 21 5 (2001) 505-515
47. Brunel G., Brocard D., Duffort J.F., Jacquet E., Justumus P., Simonet T., et al. Bioabsorbable materials for guided bone regeneration prior to implant placement and 7-year follow-up: report of 14 cases. J Periodontol 72 2 (2001) 257-264
48. Yildirim M., Spiekermann H., Biesterfeld S., and Edelhoff D. Maxillary sinus augmentation using xenogenic bone substitute material Bio-Oss in combination with venous blood. A histologic and histomorphometric study in humans. Clin Oral Implants Res 11 3 (2000) 217-229