Nasal profile changes after LeFort I osteotomy (maxillary advancement) with and without ANS reduction in class III skeletal patients: a study protocol for a randomized clinical trial.

BACKGROUND: Dentofacial malformation is a common condition that affects a significant portion of the population, resulting in functional and aesthetic defects. Orthognathic surgeries, such as LeFort I osteotomy, are performed to correct these abnormalities. However, the impact of these surgeries on nasal profile changes remains unclear. Additionally, the role of anterior nasal spine (ANS) reduction in maxillary advancement surgeries of 3-5 mm range is yet to be determined. This study aims to investigate the effect of ANS reduction on soft tissue profile changes following LeFort I osteotomy with a maxillary advancement range of 3-5 mm in class III skeletal patients. The hypothesis is that the changes in nasolabial angle and upper lip length will not significantly differ between patients who undergo LeFort I osteotomy with and without ANS reduction. METHOD AND DESIGN: This study is designed as a randomized controlled trial. A total of 26 class III skeletal patients with maxillofacial abnormalities will be recruited from the maxillofacial clinic of Bu-Ali and Farahikhtegan Hospitals in Tehran, Iran. Patients meeting the inclusion criteria will be randomly assigned to two groups: one group will undergo LeFort I osteotomy with ANS reduction, and the other group will undergo LeFort I osteotomy without ANS reduction. The soft tissue profile changes, specifically the nasolabial angle and upper lip length, will be evaluated and compared between the two groups. DISCUSSION: Achieving facial harmony through orthognathic surgery requires careful planning and consideration of the impact on surrounding soft tissue. The primary objective is to predict and plan for the effects on the nasolabial region. LeFort I osteotomy is a common procedure used to correct dentofacial deformities, particularly in class III patients. Maxillary advancement during this surgery can lead to changes in nasal tip position, width, and rotation, potentially due to repositioning of the anterior nasal spine and soft tissue dissection. In this study, soft tissue changes will be assessed in non-growing class III patients using cephalometric radiographs. The impact of reducing the anterior nasal spine (ANS) on nasal profile changes will be investigated for maxillary advancements of 3-5 mm. Objective measurements and patient-reported outcomes will be evaluated to gain insights into the aesthetic outcomes of orthognathic surgery. The findings will provide valuable guidance for treatment decisions and alternative options based on expected nasal profile changes. TRIAL REGISTRATION: This project was registered at The Iranian Registry of Clinical Trials (Identifier No. IRCT20210928052625N1, Website: https://www.irct.ir/trial/59171 ) and Open Science Framework (OSF) (Registration https://doi.org/10.17605/OSF.IO/X3HD4 ). 2021-06-09.