JMIR Publications

Background:

Cleft lip and palate (CLCP) is a complex congenital defect that can present a functional and aesthetic challenge particularly in the 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 aesthetic and functionally in patients with significant tissue deficiencies as well as in patients with scarring.

Objective:

To compare the outcomes of Unilateral Le Fort I Advancement and Dentoalveolar Transport Distraction in the management of large alveolar clefts, specifically focusing on: Closure of alveolar gaps, Maxillary arch form and Stability of the advanced/distracted segment and wound healing.

Methods:

This prospective observational study takes place at the Department of Oral and Maxillofacial Surgery, SGM Cancer Hospital, in collaboration with the Sharad Pawar Dental College Maharashtra, India, from April 2023 to June 2025. Unilateral alveolar clefts of 1 cm or greater in patients aged 9 to 25 years will be included. Patients with smaller clefts, bilateral clefts or those who are unsuitable for surgery will be exempt under exclusion criteria. The study will evaluate 14 patients, divided into two groups: Group A will get dentoalveolar transport distraction whilst Group B will have unilateral Le Fort I advancement. It will be assessed with Closure of alveolar gap, Arch form, Stability of advanced/distracted segment and Soft Tissue Healing. Through Cone beam computed tomography (CBCT) and Maxillary occlusal view, radiographic parameters of closure of alveolar gap and arch form will be evaluated. The outcome measures will be statistically analysed on RStudio software with appropriate tests applied to each outcome measures. The p-value <0.05 will be considered significant.

Results:

As of June 2025, institutional ethical clearance has been obtained and patient recruitment is ongoing. Recruitment began in June 2023 and is ongoing, 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 two graft-less 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.

Clinicaltrial:

International Registered Report:

DERR1-10.2196/77210