{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T18:57:35Z","timestamp":1791226655980,"version":"4.1.0"},"reference-count":0,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[1997,12,1]],"date-time":"1997-12-01T00:00:00Z","timestamp":880934400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Periodontology"],"published-print":{"date-parts":[[1997,12]]},"abstract":"<jats:p>T<jats:sc>he primary objective of this study<\/jats:sc> was to assess the safety of recombinant human (rh) platelet\u2010derived growth factor\u2010BB (PDGF\u2010BB) and (rh) insulin\u2010like growth factor\u2010I (IGF\u2010I) when applied to periodontal osseous defects in humans; a secondary objective was to begin to accrue data on the therapeutic dose of these growth factors (GFs) required to stimulate periodontal regeneration. Thirty\u2010eight human subjects possessing bilateral osseous periodontal lesions were assigned to one of two treatment groups in a split\u2010mouth design. Following full\u2010thickness flap reflection, test sites received local application of the therapeutic drug delivered in coded syringes by a \u201cmasked\u201d investigator. Two dose levels were tested, 50 \u03bcg\/ml each of rhPDGF\u2010BB and rhIGF\u2010I in a gel vehicle (LD\u2010PDGF\/IGF\u2010I) and 150 \u03bcg\/ml each of rhPDGF\u2010BB and rhIGF\u2010I plus vehicle (HD\u2010PDGF\/IGF\u2010I). Control treatment consisted of either conventional periodontal flap surgery or surgery plus vehicle. Safety analyses included physical examination, hematology, serum chemistry, urinalysis, antibody titers, and radiographic evaluation of bony changes. The primary therapeutic assessment was bone fill measured at re\u2010entry 6 to 9 months after treatment. No local or systemic safety issues were found as a result of GF administration. No patients developed antibodies to the rhGF proteins. In subjects treated with LD\u2010PDGF\/IGF\u2010I, there were no enhancements in periodontal regeneration compared to controls. However, in patients treated with HD\u2010PDGF\/IGF\u2010I, statistically significant increases in alveolar bone formation were noted as measured by surgical re\u2010entry 9 months following drug delivery (<jats:italic>P<\/jats:italic> &lt; 0.05). This corresponded to an increase of 2.08 mm of new vertical bone height and 42.3% osseous defect fill in the HD\u2010PDGF\/IGF\u2010I subjects versus only 0.75 mm and 18.5% gains in new bone height and osseous fill, respectively, in the controls. Furcation lesions, although limited in number, responded most favorably to treatment, with 2.8 mm horizontal osseous fill. The results from this study suggest that the local application of rhPDGF\u2010BB and rhIGF\u2010I to periodontal lesions is safe at the dose levels studied. LDPDGF\/IGF\u2010I did not elicit increased defect fill compared to the control; however, HDPDGF\/IGF\u2010I resulted in a significant promotion in bone regeneration. Additional studies are warranted to more fully characterize the effects of PDGF\/IGF\u2010I on periodontal regeneration in humans. <jats:italic>J Periodontol 1997;68:1186\u20131193<\/jats:italic>.<\/jats:p>","DOI":"10.1902\/jop.1997.68.12.1186","type":"journal-article","created":{"date-parts":[[2012,3,20]],"date-time":"2012-03-20T17:07:42Z","timestamp":1332263262000},"page":"1186-1193","source":"Crossref","is-referenced-by-count":311,"title":["A Phase I\/II Clinical Trial to Evaluate a Combination of Recombinant Human Platelet\u2010Derived Growth Factor\u2010BB and Recombinant Human Insulin\u2010Like Growth Factor\u2010I in Patients with Periodontal Disease"],"prefix":"10.1002","volume":"68","author":[{"given":"T. Howard","family":"Howell","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph P.","family":"Fiorellini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David W.","family":"Paquette","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Offenbacher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William V.","family":"Giannobile","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel E.","family":"Lynch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[1997,12]]},"container-title":["Journal of Periodontology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1902\/jop.1997.68.12.1186","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aap.onlinelibrary.wiley.com\/doi\/pdf\/10.1902\/jop.1997.68.12.1186","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T11:41:13Z","timestamp":1760874073000},"score":1,"resource":{"primary":{"URL":"https:\/\/aap.onlinelibrary.wiley.com\/doi\/10.1902\/jop.1997.68.12.1186"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1997,12]]},"references-count":0,"journal-issue":{"issue":"12","published-print":{"date-parts":[[1997,12]]}},"alternative-id":["10.1902\/jop.1997.68.12.1186"],"URL":"https:\/\/doi.org\/10.1902\/jop.1997.68.12.1186","archive":["Portico"],"relation":{},"ISSN":["0022-3492","1943-3670"],"issn-type":[{"value":"0022-3492","type":"print"},{"value":"1943-3670","type":"electronic"}],"subject":[],"published":{"date-parts":[[1997,12]]}}}