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Matsuo Yamamoto - One of the best experts on this subject based on the ideXlab platform.

  • randomized placebo controlled and controlled non inferiority phase iii trials comparing trafermin a recombinant human fibroblast growth factor 2 and enamel matrix derivative in periodontal regeneration in intrabony defects
    Journal of Bone and Mineral Research, 2016
    Co-Authors: Masahiro Kitamura, Motoki Akamatsu, Masamitsu Kawanami, Yasushi Furuichi, Takeo Fujii, Mari Mori, Kazushi Kunimatsu, Hidetoshi Shimauchi, Yorimasa Ogata, Matsuo Yamamoto
    Abstract:

    We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during Flap Surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n = 208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n = 100; p < 0.001). The other endpoint, the clinical attachment level regained at 36 weeks, was not significantly different between groups. Study B, a multicenter, randomized, blinded (patients and evaluators of radiographs), and active-controlled study was conducted at 15 centers to clarify the clinical significance of rhFGF-2. Patients with 6-mm and 4-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 274 patients were randomly assigned (5:5:2) to receive rhFGF-2, enamel matrix derivative (EMD), or Flap Surgery alone. A total of 267 patients received the assigned treatment during Flap Surgery. The primary endpoint, the linear alveolar bone growth at 36 weeks, was 1.927 mm (95% CI, 1.6615 to 2.1920; n = 108) in the rhFGF-2 group and 1.359 mm (95% CI, 1.0683 to 1.6495; n = 109) in the EMD group, showing non-inferiority (a prespecified margin of 0.3 mm) and superiority of rhFGF-2 to EMD. Safety problems were not identified in either study. Therefore, trafermin is an effective and safe treatment for periodontal regeneration in intrabony defect, and its efficacy was superior in rhFGF-2 compared to EMD treatments.

  • randomized placebo controlled and controlled non inferiority phase iii trials comparing trafermin a recombinant human fibroblast growth factor 2 and enamel matrix derivative in periodontal regeneration in intrabony defects
    Journal of Bone and Mineral Research, 2016
    Co-Authors: Masahiro Kitamura, Motoki Akamatsu, Masamitsu Kawanami, Yasushi Furuichi, Takeo Fujii, Mari Mori, Kazushi Kunimatsu, Hidetoshi Shimauchi, Yorimasa Ogata, Matsuo Yamamoto
    Abstract:

    We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during Flap Surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n = 208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n = 100; p < 0.001). The other endpoint, the clinical attachment level regained at 36 weeks, was not significantly different between groups. Study B, a multicenter, randomized, blinded (patients and evaluators of radiographs), and active-controlled study was conducted at 15 centers to clarify the clinical significance of rhFGF-2. Patients with 6-mm and 4-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 274 patients were randomly assigned (5:5:2) to receive rhFGF-2, enamel matrix derivative (EMD), or Flap Surgery alone. A total of 267 patients received the assigned treatment during Flap Surgery. The primary endpoint, the linear alveolar bone growth at 36 weeks, was 1.927 mm (95% CI, 1.6615 to 2.1920; n = 108) in the rhFGF-2 group and 1.359 mm (95% CI, 1.0683 to 1.6495; n = 109) in the EMD group, showing non-inferiority (a prespecified margin of 0.3 mm) and superiority of rhFGF-2 to EMD. Safety problems were not identified in either study. Therefore, trafermin is an effective and safe treatment for periodontal regeneration in intrabony defect, and its efficacy was superior in rhFGF-2 compared to EMD treatments. © 2015 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).

Raymond A Yukna - One of the best experts on this subject based on the ideXlab platform.

  • multi center clinical comparison of combination anorganic bovine derived hydroxyapatite matrix abm cell binding peptide p 15 and abm in human periodontal osseous defects 6 month results
    Journal of Periodontology, 2000
    Co-Authors: Raymond A Yukna, Jack T Krauser, Donald P Callan, Gerald H Evans, Renee Cruz, Millicent Martin
    Abstract:

    Background: Intraosseous periodontal defects present a particular treatment problem. New bone replacement grafts offer promise for improved results. Methods: The role of a synthetic cell-binding peptide (P-15), combined with an anorganic bovine-derived hydroxyapatite bone matrix (ABM), was compared to ABM alone in human periodontal osseous defects in a controlled, monitored, multi-center trial. Following appropriate initial preparation procedures, Flap Surgery with defect and root debridement was performed. Two osseous defects per patient were treated randomly with each procedure after surgical preparation. Appropriate periodontal maintenance schedules were followed, and at 6 to 7 months, re-entry Flap Surgery was performed for documentation and finalization of treatment. Results: T test and Mann-Whitney U analyses of patient mean values from 33 patients revealed that the combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 2.9 ± 1.2 mm (72.9%) versus a mean defect fill of 2.2...

  • multi center clinical evaluation of combination anorganic bovine derived hydroxyapatite matrix abm cell binding peptide p 15 as a bone replacement graft material in human periodontal osseous defects 6 month results
    Journal of Periodontology, 1998
    Co-Authors: Raymond A Yukna, Jack T Krauser, Donald P Callan, Gerald H Evans, Renee Cruz, Mary E Aichelmannreidy, Kent Moore, Brent J Scott
    Abstract:

    A synthetic cell-binding peptide (P-15) combined with anorganic bovine-derived hydroxyapatite bone matrix (ABM) was compared to deminerahzed freeze-dried bone allograft (DFDBA) and open Flap debridement (DEBR) in human periodontal osseous defects in a controlled, monitored, multi-center trial. Following appropriate initial preparation procedures, Flap Surgery with defect and root debridement was performed. Three osseous defects per patient were treated randomly with one of three procedures after surgical preparation. Appropriate periodontal maintenance schedules were followed, and at 6 to 7 months re-entry Flap Surgery was performed for documentation and finahzation of treatment. Analysis of variation (ANOVA) and t test analyses of patient mean values from 31 patients revealed that the combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 2.8 ± 1.2 mm (72.3%) versus a mean defect fill of 2.0 ± 1.4 mm (51.4%) for defects treated with DFDBA (P <0.05) and a mean defect fill of 1.5...

Warren M Rozen - One of the best experts on this subject based on the ideXlab platform.

  • enhanced preoperative deep inferior epigastric artery perforator Flap planning with a 3d printed perforasome template technique and case report
    Plastic and reconstructive surgery. Global open, 2018
    Co-Authors: Michael P Chae, David J Huntersmith, Marie Rostek, Julian A Smith, Warren M Rozen
    Abstract:

    : Optimizing preoperative planning is widely sought in deep inferior epigastric artery perforator (DIEP) Flap Surgery. One reason for this is that rates of fat necrosis remain relatively high (up to 35%), and that adjusting Flap design by an improved understanding of individual perforasomes and perfusion characteristics may be useful in reducing the risk of fat necrosis. Imaging techniques have substantially improved over the past decade, and with recent advances in 3D printing, an improved demonstration of imaged anatomy has become available. We describe a 3D-printed template that can be used preoperatively to mark out a patient's individualized perforasome for Flap planning in DIEP Flap Surgery. We describe this "perforasome template" technique in a case of a 46-year-old woman undergoing immediate unilateral breast reconstruction with a DIEP Flap. Routine preoperative computed tomographic angiography was performed, with open-source software (3D Slicer, Autodesk MeshMixer and Cura) and a desktop 3D printer (Ultimaker 3E) used to create a template used to mark intra-Flap, subcutaneous branches of deep inferior epigastric artery (DIEA) perforators on the abdomen. An individualized 3D printed template was used to estimate the size and boundaries of a perforasome and perfusion map. The information was used to aid Flap design. We describe a new technique of 3D printing a patient-specific perforasome template that can be used preoperatively to infer perforasomes and aid Flap design.

  • the importance of the superficial venous anatomy of the abdominal wall in planning a superficial inferior epigastric artery siea Flap case report and clinical study
    Microsurgery, 2011
    Co-Authors: Warren M Rozen, Daniel Chubb, Iain S Whitaker, Mark W. Ashton
    Abstract:

    The importance of the venous drainage of the anterior abdominal wall to free tissue transfer in deep inferior epigastric artery perforator Flap Surgery has been highlighted in several recent publications in this journal, however the same attention has not been given to superficial inferior epigastric artery (SIEA) Flaps, in which the Flap necessarily relies on the superficial venous drainage. We describe a unique case, in which the presence of two superficial inferior epigastric veins (SIEVs) draining into separate venous trunks was identified. The use of only one trunk led to a well-demarcated zone of venous congestion. A clinical study was also conducted, assessing 200 hemiabdominal walls with preoperative computed tomographic angiography imaging. The presence of more than a single major SIEV trunk was present in 80 hemiabdominal walls (40% of overall sides). There was considerable variability in the source of drainage of the SIEV, draining variably into the deep inferior epigastric vein, the great saphenous vein, the saphenous bulb, a common trunk with the superficial circumflex iliac vein or a common trunk with a second branch of the SIEV. These findings highlight the considerable variation in the number of SIEV trunks as well as their source of regional drainage, and show the importance of consideration of such variation. V C 2011 Wiley-Liss, Inc. MicroSurgery 31:454–457, 2011. The importance of the venous drainage of the anterior abdominal wall to free tissue transfer in deep inferior epigastric artery perforator (DIEP) Flap Surgery has been highlighted in several recent publications in this journal. 1–3 This has mirrored previous clinical, imaging and anatomical studies that have also highlighted this anatomy as paramount to success in DIEP Flap Surgery, with venous problems the more frequently encountered vascular complications seen. 4–9 To this end, many authors have

Masahiro Kitamura - One of the best experts on this subject based on the ideXlab platform.

  • randomized placebo controlled and controlled non inferiority phase iii trials comparing trafermin a recombinant human fibroblast growth factor 2 and enamel matrix derivative in periodontal regeneration in intrabony defects
    Journal of Bone and Mineral Research, 2016
    Co-Authors: Masahiro Kitamura, Motoki Akamatsu, Masamitsu Kawanami, Yasushi Furuichi, Takeo Fujii, Mari Mori, Kazushi Kunimatsu, Hidetoshi Shimauchi, Yorimasa Ogata, Matsuo Yamamoto
    Abstract:

    We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during Flap Surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n = 208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n = 100; p < 0.001). The other endpoint, the clinical attachment level regained at 36 weeks, was not significantly different between groups. Study B, a multicenter, randomized, blinded (patients and evaluators of radiographs), and active-controlled study was conducted at 15 centers to clarify the clinical significance of rhFGF-2. Patients with 6-mm and 4-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 274 patients were randomly assigned (5:5:2) to receive rhFGF-2, enamel matrix derivative (EMD), or Flap Surgery alone. A total of 267 patients received the assigned treatment during Flap Surgery. The primary endpoint, the linear alveolar bone growth at 36 weeks, was 1.927 mm (95% CI, 1.6615 to 2.1920; n = 108) in the rhFGF-2 group and 1.359 mm (95% CI, 1.0683 to 1.6495; n = 109) in the EMD group, showing non-inferiority (a prespecified margin of 0.3 mm) and superiority of rhFGF-2 to EMD. Safety problems were not identified in either study. Therefore, trafermin is an effective and safe treatment for periodontal regeneration in intrabony defect, and its efficacy was superior in rhFGF-2 compared to EMD treatments.

  • randomized placebo controlled and controlled non inferiority phase iii trials comparing trafermin a recombinant human fibroblast growth factor 2 and enamel matrix derivative in periodontal regeneration in intrabony defects
    Journal of Bone and Mineral Research, 2016
    Co-Authors: Masahiro Kitamura, Motoki Akamatsu, Masamitsu Kawanami, Yasushi Furuichi, Takeo Fujii, Mari Mori, Kazushi Kunimatsu, Hidetoshi Shimauchi, Yorimasa Ogata, Matsuo Yamamoto
    Abstract:

    We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during Flap Surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n = 208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n = 100; p < 0.001). The other endpoint, the clinical attachment level regained at 36 weeks, was not significantly different between groups. Study B, a multicenter, randomized, blinded (patients and evaluators of radiographs), and active-controlled study was conducted at 15 centers to clarify the clinical significance of rhFGF-2. Patients with 6-mm and 4-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 274 patients were randomly assigned (5:5:2) to receive rhFGF-2, enamel matrix derivative (EMD), or Flap Surgery alone. A total of 267 patients received the assigned treatment during Flap Surgery. The primary endpoint, the linear alveolar bone growth at 36 weeks, was 1.927 mm (95% CI, 1.6615 to 2.1920; n = 108) in the rhFGF-2 group and 1.359 mm (95% CI, 1.0683 to 1.6495; n = 109) in the EMD group, showing non-inferiority (a prespecified margin of 0.3 mm) and superiority of rhFGF-2 to EMD. Safety problems were not identified in either study. Therefore, trafermin is an effective and safe treatment for periodontal regeneration in intrabony defect, and its efficacy was superior in rhFGF-2 compared to EMD treatments. © 2015 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research (ASBMR).

Millicent Martin - One of the best experts on this subject based on the ideXlab platform.

  • multi center clinical comparison of combination anorganic bovine derived hydroxyapatite matrix abm cell binding peptide p 15 and abm in human periodontal osseous defects 6 month results
    Journal of Periodontology, 2000
    Co-Authors: Raymond A Yukna, Jack T Krauser, Donald P Callan, Gerald H Evans, Renee Cruz, Millicent Martin
    Abstract:

    Background: Intraosseous periodontal defects present a particular treatment problem. New bone replacement grafts offer promise for improved results. Methods: The role of a synthetic cell-binding peptide (P-15), combined with an anorganic bovine-derived hydroxyapatite bone matrix (ABM), was compared to ABM alone in human periodontal osseous defects in a controlled, monitored, multi-center trial. Following appropriate initial preparation procedures, Flap Surgery with defect and root debridement was performed. Two osseous defects per patient were treated randomly with each procedure after surgical preparation. Appropriate periodontal maintenance schedules were followed, and at 6 to 7 months, re-entry Flap Surgery was performed for documentation and finalization of treatment. Results: T test and Mann-Whitney U analyses of patient mean values from 33 patients revealed that the combination ABM/P-15 grafts demonstrated significantly better mean defect fill of 2.9 ± 1.2 mm (72.9%) versus a mean defect fill of 2.2...