{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T17:24:50Z","timestamp":1787678690926,"version":"build-2784847793"},"reference-count":14,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Cleft lip and palate is a complex congenital defect that can present functional and esthetic challenges, particularly in patients with large alveolar clefts for which surgical management is indicated. In contrast to traditional treatment techniques such as autologous bone grafting, newer techniques include unilateral Le Fort I osteotomy advancement and dentoalveolar transport distraction osteogenesis and have been shown to be useful in the treatment of maxillary hypoplasia and large alveolar clefts. These techniques may help improve both esthetic and function in patients with substantial tissue deficiencies as well as in patients with scarring.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to compare the outcomes of unilateral Le Fort I advancement and dentoalveolar transport distraction in the management of large alveolar clefts, specifically focusing on the closure of alveolar gaps, maxillary arch form, stability of the advanced or distracted segment, and wound healing.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This prospective observational study is being conducted at the Department of Oral and Maxillofacial Surgery, Siddharth Gupta Memorial Cancer Hospital, in collaboration with the Sharad Pawar Dental College in Maharashtra, India. Patients aged 9 to 25 years with unilateral alveolar clefts measuring 1 cm or greater will be included. Patients with smaller clefts, bilateral clefts, or those who are unsuitable for surgery will be excluded. The study will evaluate 14 patients, divided into 2 groups: group A will undergo dentoalveolar transport distraction, whereas group B will undergo unilateral Le Fort I advancement. We will assess the closure of the alveolar gap, arch form, stability of the advanced or distracted segment, and soft tissue healing. Through cone beam computed tomography and maxillary occlusal view, radiographic parameters of closure of the alveolar gap and arch form will be evaluated. The outcome measures will be statistically analyzed on RStudio software, with appropriate tests applied to each outcome measure.\n P<\/jats:italic>\n <.05 will be considered significant.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n As of June 2025, institutional ethical clearance has been obtained and patient recruitment is ongoing. Recruitment began in April 2023, with 12 patients enrolled as of June 2025. Data collection is expected to be completed by December 2025, and results will be published in mid-2026.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n This study aims to provide evidence-based guidance for the management of large alveolar clefts by comparing 2 graftless surgical techniques: unilateral Le Fort I advancement and dentoalveolar transport distraction. The findings are expected to help clinicians select the most suitable surgical approach based on individual case requirements, cleft morphology, and long-term outcome expectations. Ultimately, the study will contribute to optimizing cleft care strategies with reduced donor site morbidity and improved postoperative stability.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/77210","type":"journal-article","created":{"date-parts":[[2025,7,31]],"date-time":"2025-07-31T09:25:07Z","timestamp":1753953907000},"page":"e77210-e77210","source":"Crossref","is-referenced-by-count":0,"title":["1Unilateral Le Fort I Advancement Versus Dentoalveolar Transport Distraction in Patients With Large Alveolar Clefts: Protocol for a Prospective Observational Study"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-6983-3266","authenticated-orcid":false,"given":"Kundan Shibjee","family":"Jha","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8140-3036","authenticated-orcid":false,"given":"Nitin","family":"Bhola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,8,25]]},"reference":[{"key":"R1","doi-asserted-by":"crossref","unstructured":"Miloro M Ghali GE Larsen PE . Waite P , editor. Peterson\u2019s Principles of Oral and Maxillofacial Surgery. Springer; 2022. [doi: 10.1007\/978-3-030-91920-7] ISBN: 9783030919207","DOI":"10.1007\/978-3-030-91920-7"},{"issue":"3","key":"R2","doi-asserted-by":"publisher","first-page":"203","DOI":"10.1080\/14767050500072854","article-title":"Are isolated facial cleft lip and palate associated with increased perinatal mortality? A cohort study from the West Midlands region, 1995-1997","volume":"17","author":"Ngai","journal-title":"J Matern Fetal Neonatal Med"},{"issue":"6","key":"R3","doi-asserted-by":"publisher","first-page":"840","DOI":"10.1097\/00001665-200311000-00005","article-title":"Management of alveolar clefts","volume":"14","author":"Bajaj","journal-title":"J Craniofac Surg"},{"issue":"1","key":"R4","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1016\/0002-9416(76)90258-x","article-title":"Combined orthodontic-surgical management of residual palato-alveolar cleft defects","volume":"70","author":"Boyne","journal-title":"Am J Orthod"},{"issue":"3","key":"R5","doi-asserted-by":"publisher","first-page":"219","DOI":"10.1016\/s0278-2391(97)90528-0","article-title":"Prospective evaluation of morbidity associated with iliac crest harvest for alveolar cleft grafting","volume":"55","author":"Rudman","journal-title":"J Oral Maxillofac Surg"},{"issue":"4","key":"R6","doi-asserted-by":"publisher","first-page":"1121","DOI":"10.1097\/PRS.0b013e3181845a21","article-title":"The importance of radical intravelar veloplasty during two-flap palatoplasty","volume":"122","author":"Andrades","journal-title":"Plast Reconstr Surg"},{"issue":"1","key":"R7","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1097\/00006534-199289010-00001","volume":"89","author":"McCarthy","journal-title":"Plast Reconstr Surg"},{"issue":"2","key":"R8","doi-asserted-by":"publisher","first-page":"e187","DOI":"10.1097\/SCS.0000000000008260","article-title":"Outcomes of bifocal transport distraction osteogenesis for repairing complicated unilateral alveolar cleft","volume":"33","author":"Altaweel","journal-title":"J Craniofac Surg"},{"issue":"6","key":"R9","doi-asserted-by":"publisher","first-page":"688","DOI":"10.1016\/j.tripleo.2010.08.002","article-title":"Maxillary segmental distraction in children with unilateral clefts of lip, palate, and alveolus","volume":"111","author":"Zemann","journal-title":"Oral Surg Oral Med Oral Pathol Oral Radiol Endod"},{"issue":"1","key":"R10","doi-asserted-by":"publisher","DOI":"10.1186\/s12903-023-03038-3","article-title":"Maxillary anterior segmental distraction osteogenesis to correct maxillary hypoplasia and dental crowding in cleft palate patients: a preliminary study","volume":"23","author":"Qian","journal-title":"BMC Oral Health"},{"issue":"3","key":"R11","doi-asserted-by":"publisher","first-page":"e289","DOI":"10.1097\/SCS.0000000000002536","article-title":"Unilateral Le Fort I osteotomy for rehabilitating the large alveolar cleft and vertical malocclusion with the distraction technique","volume":"27","author":"Baykul","journal-title":"J Craniofac Surg"},{"issue":"2","key":"R12","doi-asserted-by":"publisher","first-page":"277","DOI":"10.1016\/j.jobcr.2021.02.008","article-title":"Closure of large alveolar defect by maxillary alveolar distraction using a vector-controlled distractor appliance in cleft patients: a pilot study","volume":"11","author":"Singh","journal-title":"J Oral Biol Craniofac Res"},{"key":"R13","doi-asserted-by":"publisher","DOI":"10.2196\/41870","article-title":"The development, deployment, and evaluation of the CLEFT-Q computerized adaptive test: a multimethods approach contributing to personalized, person-centered health assessments in plastic surgery","volume":"25","author":"Harrison","journal-title":"J Med Internet Res"},{"key":"R14","doi-asserted-by":"publisher","DOI":"10.3389\/fsurg.2022.932164","article-title":"A bibliometric analysis of research on craniomaxillofacial distraction osteogenesis from 2000 to 2021","volume":"9","author":"Liu","journal-title":"Front Surg"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","deposited":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T16:54:40Z","timestamp":1787676880000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e77210"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,25]]},"references-count":14,"URL":"https:\/\/doi.org\/10.2196\/77210","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,25]]},"article-number":"v15i3e77210"}}