{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T16:12:40Z","timestamp":1790784760815,"version":"4.1.0"},"reference-count":8,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,8,28]],"date-time":"2021-08-28T00:00:00Z","timestamp":1630108800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,8,28]],"date-time":"2021-08-28T00:00:00Z","timestamp":1630108800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Science and Engineering Board, Department of Science and Technology, Govt. of India","award":["CRG\/2019\/005689"],"award-info":[{"award-number":["CRG\/2019\/005689"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2021,12]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n An alveolar cleft commonly affects 75% of cleft lip and palate patients. While it is common practice to provide a course of orthodontic treatment before alveolar bone grafting, there are\u00a0no previous high-quality studies reporting on the benefits of this type of treatment.<\/jats:p>\n <\/jats:sec>\n \n Aim<\/jats:title>\n The aim of the study is to evaluate the effectiveness of pre-alveolar bone graft orthodontics for unilateral non-syndromic cleft palate patients.<\/jats:p>\n <\/jats:sec>\n \n Method<\/jats:title>\n The PABO trial is a multicentric, parallel, two-arm, single-blinded randomised controlled trial. The inclusion criteria include unilateral cleft alveolus patients requiring bone graft and between the age group of 8 and 13 years with erupted upper central incisors. Participants will be recruited at three centres across India. Participants will be randomised to orthodontic treatment or no orthodontic treatment group. Both groups of participants will have alveolar bone graft surgery and will be followed up for 6 months after surgery. The primary outcome will be the success of the alveolar bone graft measured by anterior oblique radiograph and secondary outcomes include quality of life, cost analysis and quality of the\u00a0dento-occlusal outcome. Data analysis will be carried out by an independent statistician at the end of the study.<\/jats:p>\n <\/jats:sec>\n \n Discussion<\/jats:title>\n This study is the first to evaluate the effect of orthodontics on alveolar bone graft success. The increased burden of care for these patients with multiple treatments required from multiple specialists from birth to adult life highlights the need for reducing unnecessary treatment provision.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Clinical Trials Registry \u2013 India,\n CTRI\/2020\/10\/028756<\/jats:ext-link>\n . Trial prospectively registered on 29 October 2020.\n <\/jats:p>\n .<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s13063-021-05505-0","type":"journal-article","created":{"date-parts":[[2021,8,28]],"date-time":"2021-08-28T06:02:37Z","timestamp":1630130557000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)\u2014\u00a0A\u00a0study protocol for a multicentric randomised controlled trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7809-8111","authenticated-orcid":false,"given":"Badri","family":"Thiruvenkatachari","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Altaf","family":"Hussain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Puneet","family":"Batra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charanya","family":"Vijayakumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manoj","family":"Prathap. C","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,8,28]]},"reference":[{"issue":"3","key":"5505_CR1","first-page":"216","volume":"24","author":"AP Vanderas","year":"1987","unstructured":"Vanderas AP. Incidence of cleft lip, cleft palate, and cleft lip and palate among races: a review. Cleft Palate J. 1987;24(3):216\u201325.","journal-title":"Cleft Palate J"},{"issue":"Suppl","key":"5505_CR2","doi-asserted-by":"publisher","first-page":"S9","DOI":"10.4103\/0970-0358.57182","volume":"42","author":"P Mossey","year":"2009","unstructured":"Mossey P, Little J. Addressing the challenges of cleft lip and palate research in India. Indian J Plast Surg. 2009;42(Suppl):S9\u2013S18.","journal-title":"Indian J Plast Surg"},{"issue":"3","key":"5505_CR3","doi-asserted-by":"publisher","first-page":"167","DOI":"10.1038\/nrg2933","volume":"12","author":"MJ Dixon","year":"2011","unstructured":"Dixon MJ, Marazita ML, Beaty TH, Murray JC. Cleft lip and palate: understanding genetic and environmental influences. Nat Rev Genet. 2011;12(3):167\u201378. https:\/\/doi.org\/10.1038\/nrg2933.","journal-title":"Nat Rev Genet"},{"issue":"1","key":"5505_CR4","doi-asserted-by":"publisher","first-page":"91","DOI":"10.4103\/ams.ams_196_17","volume":"8","author":"SM Balaji","year":"2018","unstructured":"Balaji SM. Burden of orofacial clefting in India, 2016: a global burden of disease approach. Ann Maxillofac Surg. 2018;8(1):91\u2013100. https:\/\/doi.org\/10.4103\/ams.ams_196_17.","journal-title":"Ann Maxillofac Surg"},{"key":"5505_CR5","doi-asserted-by":"crossref","unstructured":"Guo J, Li C, Zhang Q, Wu G, Deacon SA, Chen J, Hu H, Zou S, Ye Q. Secondary bone grafting for alveolar cleft in children with cleft lip or cleft lip and palate. Cochrane Database of Systematic Reviews. 2011;(6).","DOI":"10.1002\/14651858.CD008050.pub2"},{"issue":"3","key":"5505_CR6","doi-asserted-by":"publisher","first-page":"192","DOI":"10.1016\/S1073-8746(96)80014-4","volume":"2","author":"PD Waite","year":"1996","unstructured":"Waite PD, Waite DE. Bone grafting for the alveolar cleft defect. [Review]. Semin Orthod. 1996;2(3):192\u20136. https:\/\/doi.org\/10.1016\/S1073-8746(96)80014-4.","journal-title":"Semin Orthod"},{"key":"5505_CR7","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1016\/0002-9416(76)90258-X","volume":"70","author":"PSN Boyne","year":"1976","unstructured":"Boyne PSN. Comdined orthodontic surgical management of residual palato alveolar cleft defects. Am J Orthod. 1976;70:20\u201337.","journal-title":"Am J Orthod"},{"key":"5505_CR8","doi-asserted-by":"publisher","first-page":"71","DOI":"10.1038\/sj.bdj.4810891","volume":"2","author":"H Travesss","year":"2004","unstructured":"Travesss H, Roberts-Harry D. SJ. Risks in Orthodontic treatment. Br Dent J. 2004;2:71\u20137.","journal-title":"Br Dent J"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05505-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05505-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05505-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,28]],"date-time":"2021-08-28T18:03:20Z","timestamp":1630173800000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05505-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,28]]},"references-count":8,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5505"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05505-0","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,8,28]]},"assertion":[{"value":"12 May 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 August 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 August 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval was obtained by Institutional review. Ref no: SBDCH\/IEC\/12\/2020\/01. Written informed consent will be obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The sponsor has no role in the design of the study; in the collection, analysis, or interpretation of the data; and in the writing of the manuscript. The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"572"}}