{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T17:00:57Z","timestamp":1781629257464,"version":"3.54.5"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T00:00:00Z","timestamp":1767830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T00:00:00Z","timestamp":1770163200000},"content-version":"vor","delay-in-days":27,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Pharm Health Care Sci"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Oral lichen planus (OLP) is a chronic immune-mediated inflammatory disease of the oral mucosa that frequently causes erosive lesions accompanied by pain, thereby impairing the patient\u2019s ability to eat and drink and their overall quality of life (QOL). Current guidelines recommend topical corticosteroids as first-line treatments; however, their efficacy is limited for pain relief, and long-term safety remains a concern. Nonsteroidal anti-inflammatory drug mouthrinse formulations can deliver high local drug concentrations to the symptomatic mucosa with minimal systemic exposure. This study evaluated the short- and long-term safety and efficacy of ibuprofen gargling in patients with painful OLP.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We conducted a randomized, double-blind, placebo-controlled crossover study (Days 1\u20137), followed by a 6-month open-label long-term extension (LTE) study (Days 8\u2013176). Patients with OLP and baseline oral pain of \u2265\u200920\u00a0mm on a 100-mm visual analog scale (VAS) were enrolled. The LTE study\u2019s primary endpoint was safety, and secondary endpoints included changes in the VAS in resting oral pain and oral health-related QOL, which was measured using the Patient-Reported Oral Mucositis Symptom (PROMS) scale.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The crossover study enrolled 24 patients, and 18 patients continued the LTE study. No serious adverse events were observed. One patient discontinued treatment because of grade 2 oral pain, while the remaining patients tolerated long-term treatment exhibiting stable laboratory values. During the LTE study, ibuprofen gargling was associated with significant improvements in several PROMS domains. The most pronounced effects were observed in the dietary domains, including eating restriction (\u03b2\n day<\/jats:sub>\n = \u2212\u20090.083,\n p<\/jats:italic>\n \u2009<\u20090.001) and difficulty eating hard foods (\u03b2\n day<\/jats:sub>\n = \u2212\u20090.067,\n p<\/jats:italic>\n \u2009<\u20090.001). Modest but significant improvements were observed for mouth pain (\u03b2\n day<\/jats:sub>\n = \u2212\u20090.038,\n p<\/jats:italic>\n \u2009=\u20090.029), difficulty eating soft foods (\u03b2\n day<\/jats:sub>\n = \u2212\u20090.021,\n p<\/jats:italic>\n \u2009<\u20090.001), swallowing (\u03b2\n day<\/jats:sub>\n = \u2212\u20090.007,\n p<\/jats:italic>\n \u2009<\u20090.001), and drinking (\u03b2\n day<\/jats:sub>\n = \u2212\u20090.006,\n p<\/jats:italic>\n \u2009=\u20090.043).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n A 6-month regimen of ibuprofen gargling may be safe and associated with modest and gradual improvements in pain and oral function-related QOL in patients with OLP. Further confirmatory study is needed to confirm the potential therapeutic role of ibuprofen gargling.<\/jats:p>\n <\/jats:sec>\n \n Trail registration<\/jats:title>\n The Registry of Clinical Trials; jRCTs051220009 and jRCTs051220010, date of registration: 22 April 2022.<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s40780-025-00536-0","type":"journal-article","created":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T09:16:09Z","timestamp":1767863769000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Ibuprofen gargle for quality of life and pain improvement in oral lichen planus: randomized crossover and long-term extension phase II study"],"prefix":"10.1186","volume":"12","author":[{"given":"Yumi","family":"Kitahiro","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasumasa","family":"Kakei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Ioroi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nanae","family":"Yatagai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiko","family":"Kashin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Kobayashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asami","family":"Morioka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiro","family":"Yamamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takumi","family":"Hasegawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaya","family":"Akashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ikuko","family":"Yano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,8]]},"reference":[{"issue":"1","key":"536_CR1","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1111\/j.1365-2753.2009.01124.x","volume":"16","author":"P L\u00f3pez-Jornet","year":"2010","unstructured":"L\u00f3pez-Jornet P, Camacho-Alonso F. Quality of life in patients with oral lichen planus. J Eval Clin Pract. 2010;16(1):111\u20133. https:\/\/doi.org\/10.1111\/j.1365-2753.2009.01124.x.","journal-title":"J Eval Clin Pract"},{"issue":"3","key":"536_CR2","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1016\/j.oooo.2022.11.006","volume":"135","author":"RA Ashshi","year":"2023","unstructured":"Ashshi RA, Stanbouly D, Maisano PG, et al. Quality of life in patients with oral potentially malignant disorders: oral lichen planus and oral epithelial dysplasia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2023;135(3):363\u201371. https:\/\/doi.org\/10.1016\/j.oooo.2022.11.006.","journal-title":"Oral Surg Oral Med Oral Pathol Oral Radiol"},{"issue":"2","key":"536_CR3","doi-asserted-by":"publisher","first-page":"CD001168","DOI":"10.1002\/14651858.CD001168.pub3","volume":"28","author":"G Lodi","year":"2020","unstructured":"Lodi G, Manfredi M, Mercadante V, et al. Interventions for treating oral lichen planus: corticosteroid therapies. Cochrane Database Syst Rev. 2020;28(2):CD001168. https:\/\/doi.org\/10.1002\/14651858.CD001168.pub3.","journal-title":"Cochrane Database Syst Rev"},{"key":"536_CR4","doi-asserted-by":"publisher","first-page":"612","DOI":"10.1186\/s40780-020-00168-6","volume":"1","author":"T Ioroi","year":"2020","unstructured":"Ioroi T, Kiyota N, Imamura Y, et al. Ibuprofen gargle for chemo- or Chemoradiotherapy-induced oral mucositis: a feasibility study. J Pharm Health Care Sci. 2020;1:612. https:\/\/doi.org\/10.1186\/s40780-020-00168-6.","journal-title":"J Pharm Health Care Sci"},{"issue":"2","key":"536_CR5","doi-asserted-by":"publisher","first-page":"272","DOI":"10.3390\/clinpract11020040","volume":"7","author":"M Yuwanati","year":"2021","unstructured":"Yuwanati M, Gondivkar S, Sarode SC, et al. Impact of oral lichen planus on oral Health-Related quality of life: A systematic review and Meta-Analysis. 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The Kobe University Clinical Research Ethics Committee reviewed and approved the protocol (C210022 and C210023), and the clinical trial identifiers are jRCTs051220009 and jRCTs051220010. Written informed consent was obtained from all patients before any study procedures were conducted.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Consent for the publication was obtained from the patients.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"14"}}