{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T17:00:47Z","timestamp":1783443647898,"version":"3.54.6"},"reference-count":41,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T00:00:00Z","timestamp":1755475200000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003710","name":"Korea Health Industry Development Institute","doi-asserted-by":"publisher","award":["HI22C1684"],"award-info":[{"award-number":["HI22C1684"]}],"id":[{"id":"10.13039\/501100003710","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Dentin hypersensitivity is characterized by transient, sharp pain resulting from dentin exposure due to enamel or cementum loss. Current treatments, which primarily focus on superficial tubule occlusion or nerve desensitization, provide only temporary relief. Copine7 (CPNE7) induces odontoblast differentiation and physiologic dentin regeneration, enabling biological dentin sealing and presenting a novel therapeutic approach. This study reports the first\u2010in\u2010human results of a randomized, double\u2010blind, dose\u2010escalation phase 1\/2a clinical trial evaluating the safety, tolerability, preliminary efficacy, and pharmacokinetics of the CPNE7\u2010derived functional peptide (selcopintide) in patients with dentin hypersensitivity. In Part A (Single Ascending Dose, SAD), 24 participants received a single topical application of selcopintide at ascending doses (2.5, 5, and 10\u2009\u03bcg\/tooth) in a 6:2 randomization ratio (treatment: placebo). In Part B (Multiple Ascending Dose, MAD), 16 participants received three topical applications (5 and 10\u2009\u03bcg\/tooth) over 15\u2009days (day 1, 8, and 15; visits 2\u20134) with the same randomization ratio. Efficacy endpoints were assessed by changes in cold water, evaporative air, and tactile sensitivity. In Part B, the 10\u2009\u03bcg selcopintide group demonstrated statistically significant reductions from the baseline across all three measures (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05), with a mean decrease of \u221223.2\u2009\u00b1\u200919.4\u2009mm in VAS, the primary efficacy endpoint. All doses were well tolerated, with no serious adverse events and no detectable systemic absorption of selcopintide. These findings support the safety, tolerability, and preliminary efficacy of selcopintide as a novel therapeutic candidate for the treatment of dentin hypersensitivity.<\/jats:p>","DOI":"10.1111\/cts.70326","type":"journal-article","created":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T05:56:11Z","timestamp":1755582971000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["First\u2010In\u2010Human Study of Safety, Tolerability, Efficacy, and Pharmacokinetics of <scp>CPNE7<\/scp>\u2010Derived Peptide (Selcopintide) for Dentin Hypersensitivity"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-7758-5867","authenticated-orcid":false,"given":"Myung Jin","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Conservative Dentistry, School of Dentistry and Institute of Oral Bioscience Jeonbuk National University  Jeonju Republic of Korea"},{"name":"Research Institute of Clinical Medicine of Jeonbuk National University  Jeonju Republic of Korea"},{"name":"Biomedical Research Institute of Jeonbuk National University Hospital  Jeonju Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7196-5123","authenticated-orcid":false,"given":"Yoon Seon","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Conservative Dentistry, Dental Research Institute and School of Dentistry Seoul National University  Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3162-7557","authenticated-orcid":false,"given":"Joo\u2010Cheol","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Oral Histology\u2013Developmental Biology, Dental Research Institute and School of Dentistry Seoul National University  Seoul South Korea"},{"name":"Regenerative Dental Medicine R&amp;D Center HysensBio Co., Ltd.  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