1Unilateral Le Fort I Advancement Versus Dentoalveolar Transport Distraction in Patients With Large Alveolar Clefts: Protocol for a Prospective Observational Study.
This protocol describes a 14-patient prospective observational comparison of unilateral Le Fort I advancement and dentoalveolar transport distraction for large unilateral alveolar clefts, with recruitment ongoing and no outcome data yet reported.
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This protocol describes a 14-patient prospective observational comparison of unilateral Le Fort I advancement and dentoalveolar transport distraction for large unilateral alveolar clefts, with recruitment ongoing and no outcome data yet reported.
Research significance
The record establishes only that two graftless surgical approaches will be compared; it is hypothesized, but not yet demonstrated, that one may offer better gap closure, arch form, segment stability, or wound healing while avoiding donor-site morbidity.
Source abstract
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. P<.05 will be considered significant. RESULTS: 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. CONCLUSIONS: 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.