{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T13:52:12Z","timestamp":1773150732585,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T00:00:00Z","timestamp":1684800000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000341","name":"Arthritis Research UK","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000341","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Oral Pathology Medicine"],"published-print":{"date-parts":[[2023,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Effective treatments for dry mouth of Sjogren's syndrome are limited and hampered by adverse effects. The aim of LEONIDAS\u20101 was to explore the feasibility of salivary electrostimulation in individuals with primary Sjogren's syndrome, as well as parameters required to inform the design of a future phase III trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Multicentre, parallel\u2010group, double\u2010blind, randomised sham\u2010controlled trial in two UK centres. Participants were randomised (1:1, computer\u2010generated) to active or sham electrostimulation. The feasibility outcomes included screening\/eligibility ratio, consent, and recruitment and drop\u2010out rates. Preliminary efficacy outcome included dry mouth visual analogue scale, Xerostomia Inventory, the EULAR Sj\u00f6gren's syndrome patient reported index\u2010Q1, and unstimulated sialometry.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Forty\u2010two individuals were screened, of whom 30 (71.4%) met the eligibility criteria. All eligible individuals consented to recruitment. Out of the 30 randomised participants (active <jats:italic>n<\/jats:italic>\u2009=\u200915, sham <jats:italic>n<\/jats:italic>\u2009=\u200915), 4 dropped out and 26 (13 vs. 13) completed all study visits as per protocol. Recruitment rate was 2.73 participants\/month. At 6\u2010month post\u2010randomisation the difference in mean reduction in visual analogue scale, xerostomia inventory and EULAR Sj\u00f6gren's syndrome patient reported index\u2010Q1 scores between groups were 0.36 (95% CI: \u22120.84, 1.56), 3.31 (0.43, 6.18), and 0.23 (\u22121.17, 1.63), respectively; unstimulated salivary flow increased by a mean of 0.98\u2009mL\/15\u2009min, all in favour of the active group. No adverse events were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>LEONIDAS\u20101 results support progression to a phase III definitive randomised controlled trial of salivary electrostimulation in individuals with Sjogren's syndrome. Xerostomia inventory could be considered the primary patient\u2010centred outcome measure and the corresponding observed treatment effect could inform the sample size of a future trial.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jop.13452","type":"journal-article","created":{"date-parts":[[2023,5,23]],"date-time":"2023-05-23T17:12:43Z","timestamp":1684861963000},"page":"619-627","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Long\u2010term effectiveness of a novel intra\u2010oral electro\u2010stimulator for the treatment of dry mouth in patients with <scp>Sjogren's<\/scp> syndrome: A randomised sham\u2010controlled feasibility study (<scp>LEONIDAS<\/scp>\u20101)"],"prefix":"10.1111","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9006-9412","authenticated-orcid":false,"given":"Stefano","family":"Fedele","sequence":"first","affiliation":[{"name":"UCL Eastman Dental Institute, University College London  London UK"},{"name":"NIHR UCLH Biomedical Research Centre  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arwa","family":"Al\u2010Hamad","sequence":"additional","affiliation":[{"name":"King Abdulaziz Medical City National Guard Health Affairs  Riyadh Saudi Arabia"},{"name":"College of Dentistry King Saud Bin Abdulaziz University for Health Sciences  Riyadh Saudi Arabia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3164-854X","authenticated-orcid":false,"given":"Valeria","family":"Mercadante","sequence":"additional","affiliation":[{"name":"UCL Eastman Dental Institute, University College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Porter","sequence":"additional","affiliation":[{"name":"UCL Eastman Dental Institute, University College London  London UK"},{"name":"NIHR UCLH Biomedical Research Centre  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Isenberg","sequence":"additional","affiliation":[{"name":"Centre for Rheumatology, Division of Medicine University College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Poveda\u2010Gallego","sequence":"additional","affiliation":[{"name":"Oral Medicine Birmingham Dental Hospital and School of Dentistry  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sarah T.","family":"Brown","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research University of Leeds  Leeds UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,5,23]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)66990-5"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.14219\/jada.archive.2008.0101"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bdj.2012.890"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2842.2008.01919.x"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/030097400750001761"},{"issue":"1","key":"e_1_2_11_7_1","first-page":"63","article-title":"Functional disability and end organ damage in patients with systemic lupus erythematosus (SLE), SLE and Sj\u00f6gren's syndrome (SS), and primary SS","volume":"25","author":"Sutcliffe N","year":"1998","journal-title":"J Rheumatol"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.12968\/hmed.2014.75.9.509"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2016.100"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/odi.12952"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1741-2358.2003.00064.x"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kem078"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autneu.2006.10.006"},{"issue":"5","key":"e_1_2_11_14_1","first-page":"R1188","article-title":"Low\u2010frequency subthreshold sympathetic stimulation augments maximal reflex parasympathetic salivary secretion in cats","volume":"268","author":"Izumi H","year":"1995","journal-title":"Am J Physiol"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/00220345880670101701"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00300975"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.27766"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.oooo.2012.01.012"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i5239"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.61.6.554"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1067\/moe.2001.111551"},{"issue":"1","key":"e_1_2_11_22_1","first-page":"12","article-title":"The xerostomia inventory: a multi\u2010item approach to measuring dry mouth","volume":"16","author":"Thomson WM","year":"1999","journal-title":"Community Dent Health"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.143743"},{"issue":"6","key":"e_1_2_11_24_1","first-page":"227","article-title":"Secretion rate and buffer effect of resting and stimulated whole saliva as a function of age and sex","volume":"7","author":"Heintze U","year":"1983","journal-title":"Swed Dent J"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/j..2002.384.doc.x"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keq240"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2017-212268"},{"issue":"5","key":"e_1_2_11_28_1","first-page":"e552","article-title":"Electrostimulation of the lingual nerve by an intraoral device may lead to salivary gland regeneration: a case series study","volume":"23","author":"Wolff A","year":"2018","journal-title":"Med Oral Patol Oral Cir Bucal"}],"container-title":["Journal of Oral Pathology &amp; Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jop.13452","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,18]],"date-time":"2023-08-18T05:40:24Z","timestamp":1692337224000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jop.13452"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,23]]},"references-count":27,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2023,8]]}},"alternative-id":["10.1111\/jop.13452"],"URL":"https:\/\/doi.org\/10.1111\/jop.13452","archive":["Portico"],"relation":{},"ISSN":["0904-2512","1600-0714"],"issn-type":[{"value":"0904-2512","type":"print"},{"value":"1600-0714","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,5,23]]},"assertion":[{"value":"2023-01-10","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-04-28","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-05-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}