{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T12:23:31Z","timestamp":1789215811334,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2010,6,8]],"date-time":"2010-06-08T00:00:00Z","timestamp":1275955200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Oral Implants Res"],"published-print":{"date-parts":[[2010,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Objectives: <\/jats:bold> The aim of this prospective, randomized clinical trial was to investigate the potential of recombinant human growth and differentiation factor\u20105 (rhGDF\u20105) coated onto \u03b2\u2010tricalcium phosphate (\u03b2\u2010TCP) (rhGDF\u20105\/\u03b2\u2010TCP) to support bone formation after sinus lift augmentation.<\/jats:p><jats:p><jats:bold>Material and methods: <\/jats:bold> In total, 31 patients participated in this multicenter clinical trial. They required a two\u2010stage unilateral maxillary sinus floor augmentation (residual bone height &lt;5\u2003mm). According to a parallel\u2010group design, the patients were randomized to three treatment groups: (a) augmentation with rhGDF\u20105\/\u03b2\u2010TCP and a 3\u2010month healing period, (b) augmentation with rhGDF\u20105\/\u03b2\u2010TCP and a 4\u2010month healing period and (c) medical device \u03b2\u2010TCP mixed with autologous bone and a 4\u2010month healing period. The primary study objective was the area of newly formed bone within the augmented area as assessed by histomorphometric evaluation of trephine bur biopsies.<\/jats:p><jats:p><jats:bold>Results: <\/jats:bold> The osseous regeneration was similar in each treatment group; the amount of newly formed bone ranged between 28% (\u00b1 15.5%) and 31.8% (\u00b1 17.9%). Detailed analysis of histological data will be published elsewhere. As secondary efficacy variables, the augmentation height at the surgery site was measured by radiography. The largest augmentation was radiologically achieved in the rhGDF\u20105\/\u03b2\u2010TCP \u2013 3\u2010month and the rhGDF\u20105\/\u03b2\u2010TCP \u2013 4\u2010month treatment groups. As safety parameters, adverse events were recorded and anti\u2010drug antibody levels were evaluated. Most of the adverse events were judged as unrelated to the study medication. Four out of 47 (8.5%) implants failed in patients treated with rhGDF\u20105\/\u03b2\u2010TCP, a result that is in agreement with the general implant failure rate of 5\u201315%. Transiently very low amounts of anti\u2010rhGDF\u20105 antibodies were detected in some patients who received rhGDF\u20105, which was not related to the bone formation outcome.<\/jats:p><jats:p><jats:bold>Conclusion: <\/jats:bold> rhGDF\u20105\/\u03b2\u2010TCP was found to be effective and safe as the control treatment with autologous bone mixed \u03b2\u2010TCP in sinus floor augmentation. Thus, further investigation regarding efficacy and safety will be carried out in larger patient populations.<\/jats:p><jats:p> <jats:bold>To cite this article:<\/jats:bold>\n          \u2028Koch FP, Becker J, Terheyden H, Capsius B, Wagner W, on behalf of the research group of this multicenter clinical trial. A prospective, randomized pilot study on the safety and efficacy of recombinant human growth and differentiation factor\u20105 coated onto \u03b2\u2010tricalcium phosphate for sinus lift augmentation.\u2028<jats:italic>Clin. Oral Impl. Res<\/jats:italic>. <jats:bold>21<\/jats:bold>, 2010; 1301\u20131308.\u2028doi: 10.1111\/j.1600\u20100501.2010.01949.x<\/jats:p>","DOI":"10.1111\/j.1600-0501.2010.01949.x","type":"journal-article","created":{"date-parts":[[2010,6,8]],"date-time":"2010-06-08T08:55:36Z","timestamp":1275987336000},"page":"1301-1308","source":"Crossref","is-referenced-by-count":52,"title":["A prospective, randomized pilot study on the safety and efficacy of recombinant human growth and differentiation factor\u20105 coated onto \u03b2\u2010tricalcium phosphate for sinus lift augmentation"],"prefix":"10.1111","volume":"21","author":[{"given":"Felix P.","family":"Koch","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen","family":"Becker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Terheyden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f6rn","family":"Capsius","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilfried","family":"Wagner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the research group of this multicenter clinical trial","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2010,6,8]]},"reference":[{"key":"e_1_2_7_2_1","first-page":"613","article-title":"Grafting of the maxillary sinus floor with autogenous marrow and bone","volume":"38","author":"Boyne P.J.","year":"1980","journal-title":"The International Journal of Oral and Maxillofacial Surgery"},{"key":"e_1_2_7_3_1","first-page":"470","article-title":"The effects of age, jaw site, and bone condition on oral implant outcomes","volume":"11","author":"Bryant S.R.","year":"1998","journal-title":"The International Journal of Prosthodontics"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1530\/eje.0.1300038"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0501.2004.01116.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0501.2007.01494.x"},{"key":"e_1_2_7_7_1","first-page":"119","article-title":"The anatomy and development of brachypodism in the mouse","volume":"30","author":"Gr\u00fcnenberg H.","year":"1973","journal-title":"Journal of Embryology and Experimental Morphology"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/0378-5122(93)90026-E"},{"key":"e_1_2_7_9_1","unstructured":"Hellerbrand K. 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