{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T17:15:07Z","timestamp":1792430107333,"version":"4.5.0"},"reference-count":25,"publisher":"BMJ","issue":"3","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,1,28]]},"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Osteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the mainstay of the early management of ORN. Literature about the efficacy of HBO is contentious. Recently, Oral and Maxillofacial surgical units in France and UK have trialled a combination of medications to treat ORN, also known as PENTOCLO (PENtoxifylline+TOcopherol\u00b1CLOdronate). This regime has shown promising results to date however randomised controlled trials in the area comparing HBO against PENTOCLO are lacking and there are no current trials registered in Europe, UK, Australia and the USA. The purpose of this pilot study is to generate a hypothesis that can be tested in large multi-centre controlled trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>For this pilot study we will recruit 16 patients who will be randomly allocated to one of either HBO or PENTOCLO. After a 4\u2009week period of uniform \u2018pre-treatment\u2019 medication patients will be commenced on their allocated treatment. Standard follow-up examination, imaging and photographs will be taken and de-identified and then presented to two Oral and Maxillofacial surgeons for allocation of a Notani &amp; Lyons classification score. Data for each patient will be tracked over the 18\u2009months of treatment and follow-up. The results will then be analysed using descriptive statistics and all patients included in an intention to treat analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval for this study has been granted by the South Metropolitan Health Service HREC (PRN RGS0000001193). Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12618001099213; Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-026662","type":"journal-article","created":{"date-parts":[[2019,3,5]],"date-time":"2019-03-05T05:14:17Z","timestamp":1551762857000},"page":"e026662","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol\u00b1 CLOdronate for the management of early osteoradionecrosis of the mandible"],"prefix":"10.1136","volume":"9","author":[{"given":"Vishal M","family":"Bulsara","sequence":"first","affiliation":[{"name":"School of Dentistry, Oral Health Centre of Western Australia, Crawley, Western Australia, Australia"},{"name":"Ear, Nose and Throat Surgery, Fiona Stanley Hospital, Murdoch, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max K","family":"Bulsara","sequence":"additional","affiliation":[{"name":"The Institute for Health Research, The University of Notre Dame, Fremantle, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Lewis","sequence":"additional","affiliation":[{"name":"Oral and Maxillofacial Surgery, Fiona Stanley Hospital, Murdoch, Western Australia, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,3,4]]},"reference":[{"key":"2025121411102921000_9.3.e026662.1","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/j.bjoms.2010.11.017","article-title":"Pentoxifylline and tocopherol in the management of patients with osteoradionecrosis, the Portsmouth experience","volume":"50","author":"McLeod","year":"2012","journal-title":"Br J Oral Maxillofac Surg"},{"key":"2025121411102921000_9.3.e026662.2","doi-asserted-by":"publisher","DOI":"10.1016\/0278-2391(83)90294-X"},{"key":"2025121411102921000_9.3.e026662.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0278-2391(83)80005-6"},{"key":"2025121411102921000_9.3.e026662.4","article-title":"Hyperbaric oxygen therapy for late radiation tissue injury","volume":"5","author":"Bennett","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121411102921000_9.3.e026662.5","doi-asserted-by":"publisher","DOI":"10.1002\/hed.20121"},{"key":"2025121411102921000_9.3.e026662.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2010.03.029"},{"key":"2025121411102921000_9.3.e026662.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjoms.2014.01.003"},{"key":"2025121411102921000_9.3.e026662.8","doi-asserted-by":"crossref","first-page":"333","DOI":"10.1016\/j.anorl.2013.11.006","article-title":"Medical treatment of osteoradionecrosis of the mandible by PENTOCLO: preliminary results","volume":"131","author":"Robard","year":"2014","journal-title":"Eur Ann Otorhinolaryngol Head Neck Dis"},{"key":"2025121411102921000_9.3.e026662.9","doi-asserted-by":"crossref","first-page":"401","DOI":"10.1016\/j.bjoms.2018.03.009","article-title":"Current trends in the medical management of osteoradionecrosis using triple therapy","volume":"56","author":"Dhanda","year":"2018","journal-title":"Br J Oral Maxillofac Surg"},{"key":"2025121411102921000_9.3.e026662.10","doi-asserted-by":"crossref","first-page":"73","DOI":"10.1016\/j.oraloncology.2016.12.002","article-title":"Refining the definition of mandibular osteoradionecrosis in clinical trials: the cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis)","volume":"64","author":"Shaw","year":"2017","journal-title":"Oral Oncol"},{"key":"2025121411102921000_9.3.e026662.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjoms.2014.02.017"},{"key":"2025121411102921000_9.3.e026662.12","doi-asserted-by":"publisher","DOI":"10.1002\/hed.10171"},{"key":"2025121411102921000_9.3.e026662.13","unstructured":"ADMINISTRATION USFD. 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