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      Randomized clinical trial on the efficacy of Escherichia coli-derived rhBMP-2 with β-TCP/HA in extraction socket

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          Abstract

          PURPOSE

          This randomized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the β-TCP bone graft material that contains ErhBMP-2.

          MATERIALS AND METHODS

          This study involved 72 patients at the 3 study centers. The patients, who were divided into 2 groups: the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction. CT was taken before and 3 months after the transplantation and healing status was compared between the two groups. The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width. The paired t test was used to determine the significance of the changes ( P<.05).

          RESULTS

          Changes in alveolar bone height were -1.087 ± 1.413 mm in the control group and -.059 ± 0.960 mm in the experimental group ( P<.01). At 25% extraction socket length [ESL], the changes were 0.006 ± 1.149 mm in the control group and 1.279 ± 1.387 mm in the experimental group. At 50% ESL, the changes were 0.542 ± 1.157 mm and 1.239 ± 1.249 mm, respectively ( P<.01 for 25% ESL, and P<.05 for 50% ESL). During the experiment, no adverse reactions to the graft material were observed.

          CONCLUSION

          ErhBMP-2 coated β-TCP/HA were found to be more effective in preserving alveolar bone than conventional β-TCP/HA alloplastic bone graft materials.

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          Most cited references18

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          Bone morphogenetic proteins in tissue engineering: the road from laboratory to clinic, part II (BMP delivery).

          Bone morphogenetic proteins (BMPs) are cytokines with a strong effect on bone and cartilage growth and with important roles during embryonic patterning and early skeletal formation. BMPs have promising potential for clinical bone and cartilage repair, working as powerful bone-inducing components in diverse tissue-engineering products. Synthetic polymers, natural origin polymers, inorganic materials and composites may be used as carriers for the delivery of BMPs. Carriers range from nanoparticles to complex three-dimensional (3D) scaffolds, membranes for tissue-guided regeneration, biomimetic surfaces and smart thermosensitive hydrogels. Current clinical uses include spinal fusion, healing of long bone defects and craniofacial and periodontal applications, amongst others. BMP-2 and BMP-7 have recently received approval by the US Food and Drug Administration (FDA) for specific clinical cases, delivered in absorbable collagen sponges. Considering the expanding number of publications in the field of BMPs, there are prospects of a brilliant future in the field of regenerative medicine of bone and cartilage with the use of BMPs.
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            The efficacy of bone replacement grafts in the treatment of periodontal osseous defects. A systematic review.

            Bone replacement grafts (BRG) are widely used in the treatment of periodontal osseous defects; however, the clinical benefits of this therapeutic practice require further clarification through a systematic review of randomized controlled studies. The purpose of this systematic review is to access the efficacy of bone replacement grafts in proving demonstrable clinical improvements in periodontal osseous defects compared to surgical debridement alone. What is the effect of bone replacement grafts compared to other interventions on clinical, radiographic, adverse, and patient-centered outcomes in patients with periodontal osseous defects? The computerized bibliographical databases MEDLINE and EMBASE were searched from 1966 and 1974, respectively, to October 2002 for randomized controlled studies in which bone replacement grafts were compared to other surgical interventions in the treatment of periodontal osseous defects. The search strategy included screening of review articles and reference lists of retrieved articles as well as hand searches of selected journals. All searches were limited to human studies in English language publications. Non-randomized observational studies (e.g., case reports, case series), publications providing summary statistics without variance estimates or data to permit computation, and studies without BRG intervention alone were excluded. The therapeutic endpoints examined included changes in bone level, clinical attachment level, probing depth, gingival recession, and crestal resorption. For purposes of meta-analysis, change in bone level (bone fill) was used as the primary outcome measure, measured upon surgical re-entry or transgingival probing (sounding). 1. Forty-nine controlled studies met eligibility criteria and provided clinical outcome data on intrabony defects following grafting procedures. 2. Seventeen studies provided clinical outcome data on BRG materials for the treatment of furcation defects. 1. With respect to the treatment of intrabony defects, the results of meta-analysis supported the following conclusions: 1) bone grafts increase bone level, reduce crestal bone loss, increase clinical attachment level, and reduce probing depth compared to open flap debridement (OFD) procedures; 2) No differences in clinical outcome measures emerge between particulate bone allograft and calcium phosphate (hydroxyapatite) ceramic grafts; and 3) bone grafts in combination with barrier membranes increase clinical attachment level and reduce probing depth compared to graft alone. 2. With respect to the treatment of furcation defects, 15 controlled studies provided data on clinical outcomes. Insufficient studies of comparable design were available to submit data to meta-analysis. Nonetheless, outcome data from these studies generally indicated positive clinical benefits with the use of grafts in the treatment of Class II furcations. 3. With respect to histological outcome parameters, 2 randomized controlled studies provide evidence that demineralized freeze-dried bone allograft (DFDBA) supports the formation of a new attachment apparatus in intrabony defects, whereas OFD results in periodontal repair characterized primarily by the formation of a long junctional epithelial attachment. Multiple observational studies provide consistent histological evidence that autogenous and demineralized allogeneic bone grafts support the formation of new attachment. Limited data also suggest that xenogenic bone grafts can support the formation of a new attachment apparatus. In contrast, essentially all available data indicate that alloplastic grafts support periodontal repair rather than regeneration. 4. The results of this systematic review indicate that bone replacement grafts provide demonstrable clinical improvements in periodontal osseous defects compared to surgical debridement alone.
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              Recombinant human bone morphogenetic protein induces bone formation.

              We have purified and characterized active recombinant human bone morphogenetic protein (BMP) 2A. Implantation of the recombinant protein in rats showed that a single BMP can induce bone formation in vivo. A dose-response and time-course study using the rat ectopic bone formation assay revealed that implantation of 0.5-115 micrograms of partially purified recombinant human BMP-2A resulted in cartilage by day 7 and bone formation by day 14. The time at which bone formation occurred was dependent on the amount of BMP-2A implanted; at high doses bone formation could be observed at 5 days. The cartilage- and bone-inductive activity of the recombinant BMP-2A is histologically indistinguishable from that of bone extracts. Thus, recombinant BMP-2A has therapeutic potential to promote de novo bone formation in humans.
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                Author and article information

                Journal
                J Adv Prosthodont
                JAP
                The Journal of Advanced Prosthodontics
                The Korean Academy of Prosthodontics
                2005-7806
                2005-7814
                September 2011
                25 September 2011
                : 3
                : 3
                : 161-165
                Affiliations
                [1 ]Department of Prosthodontics, School of Dentistry, Pusan National University, Yangsan, Korea.
                [2 ]Department of Periodontology, Section of Dentistry, Seoul National University Bundang Hospital, Sungnam, Korea.
                [3 ]Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul, Korea.
                [4 ]Department of Periodontology, In-je University Haeundae Paik Hospital, Pusan, Korea.
                [5 ]Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital, Sungnam, Korea.
                [6 ]Research & Development Institute, Cowellmedi Co., Pusan, Korea.
                [7 ]Department of Prosthodontics, Institute for Clinical Dental Research, Korea University Guro Hospital, Korea University, Seoul, Korea.
                Author notes
                Corresponding author: Young-Kyun Kim 1, Kyoo-Sung Cho 2, Sang-Wan Shin 3. 1Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital, 300 Gumi-dong, Sungnam, 463-707, Korea. Tel. 82 31 787 7541: kyk0505@ 123456freechal.com , 2Department of Periodontology, Yonsei University College of Dentistry, 134 Shinchon-dong, Seodaemun-gu, Seoul, 120-752, Korea. Tel. 82 2 2228 3189: kscho@ 123456yuhs.ac , 3Department of Prosthodontics, Institute for Clinical Dental Research, Korea University Guro Hospital, Korea University, 97, Gurodonggil, Guro-gu, Seoul, 152-703, Korea. Tel. 82 2 2626 1922: swshin@ 123456korea.ac.kr

                aThese authors contributed equally to this work.

                *These authors contributed equally to this work and they are co-corresponding authors.

                Article
                10.4047/jap.2011.3.3.161
                3204453
                22053248
                4d68a218-db41-458c-af1c-13ae22acfc80
                © 2011 The Korean Academy of Prosthodontics

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 05 August 2011
                : 31 August 2011
                : 01 September 2011
                Categories
                Original Article

                Dentistry
                tooth extraction,randomized clinical trial,β-tcp/ha,erhbmp-2,alveolar bone regeneration
                Dentistry
                tooth extraction, randomized clinical trial, β-tcp/ha, erhbmp-2, alveolar bone regeneration

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