Comparative Evaluation of Dentoalveolar Effects of Sawangi Flexiforce Expander as Against Quad Helix in Cleft Lip and Palate Patients of 7 to 12 Years in Central India Population: A Randomised Clinical Trial

Introduction: Cleft Lip and Palate (CLP) is among the most prevalent congenital craniofacial anomalies, often accompanied by maxillary hypoplasia and transverse deficiency. Surgical scarring and disrupted maxillary development in CLP patients typically lead to posterior crossbites and constriction of the maxillary arch. Orthodontic maxillary expansion is a key early intervention. Although the Quad Helix (QH) is a commonly used slow expansion appliance, it has limitations related to molar tipping and control. The Sawangi Flexiforce Expander (SFE) is a newly developed appliance designed to provide more controlled and parallel expansion, and its dentoalveolar effects were evaluated in the present study. Aim: To compare and evaluate the dentoalveolar effects of the SFE against the QH appliance in CLP patients aged 7 to 12 years in the Central India population. Materials and Methods: A prospective randomised clinical trial was conducted at the Department of Orthodontics and Dentofacial Orthopaedics, Sharad Pawar Dental College, Wardha, Maharashtra, India from December 2023 to June 2024. A total of 30 patients aged 7-12 years with unilateral CLP and maxillary constriction were randomly allocated into two groups (n=15 each). Group I was treated with a QH, and group II received the SFE. Expansion was done according to standard protocols. The Cone Beam Computed Tomography (CBCT) scans were taken before (T0) and after complete expansion of the maxillary arch i.e. after 6 months (T1,) to assess inter-canine width, inter-molar width, molar tipping, and inter-molar angle. Demographic details such as age and gender were recorded. Data were analysed using the Independent Sample t-test with Statistical Package for Social Sciences (SPSS) version 27.0, and statistical significance was set at p-value <0.05. Results: The SFE group (group II) showed significantly greater increases in inter-canine width (4.57 mm, p-value <0.0001) and inter-molar width (5.10 mm, p-value <0.001) compared to the QH group. Molar tipping was significantly lower in the group II (7.0°, p-value <0.001), indicating better control. The inter-molar angle was also significantly more favourable in group II (96.0°, p-value <0.001), reflecting more parallel and bodily expansion. Conclusion: The SFE demonstrated superior and more controlled dentoalveolar expansion than the QH, making it a promising, a cost-effective appliance for CLP patients.