The Validity of Customized Orthodontic Bracket Set up (Randomized Clinical Trial)

CAD/CAM systems have assisted orthodontists in planning and positioning brackets to minimize errors and improve the excellence of treatment. This study aimed to validate measurements obtained from manual and digital systems, as well as evaluate the effectiveness, and periodontal changes that occurred after the treatment. Materials and Methods: This study is a prospective randomized controlled trial, in which clinical evaluation of virtual setup (digital and manual) techniques versus CAD/CAM brackets (Ormco© Insignia™ .022" twin brackets) in terms of expression of bracket prescription and treatment outcome. The sample consisted of 30 young adults with Angle Class I malocclusion. Cone beam computer tomography (CBCT) were obtained before and after the treatment to assess the parallelism between the dental roots and periodontal conditions. Digital impression by three dimensional (3D) intraoral scans (IOS) will be obtained for all participants. The 3D models are converted to stereolithography (STL) for all groups. The sample will be dividing randomly into three groups; the first one treated with CAD/CAM brackets (Ormco© Insignia™ .022" twin brackets), while the other two groups were treated by customization of bracket base of the conventional pre-adjusted twin bracket with orthodontic adhesive material, this will be done through planning and creating the virtual setup by using Maestro® 3D Ortho Studio software. The Indirect bonding devices for the second group will manufacturing from 3D printed models while third group from the manual double-layer vacuum-formed thermoplastic trays. All patients will treat with fixed orthodontic twin brackets appliances. The 3D models of the Virtual setup are comparing with the treated occlusion. The linear and angular measurements are performing by the Geomagic® software and using the 3Shape's Ortho-Analyzer TM software in all groups to assess the American Board of Orthodontics grading system scores. Random errors are assessing by Intra-class Correlation Coefficient (ICC) and method errors. Descriptive statistical analysis, Shapiro-Wilk test to detect the normality of variable distribution and the Chi-square test evaluated whether the ABO scores measurements are within the limits of agreement of each criterion. ABO scores between both groups are analyze by using Wilcoxon test. The Bland-Altman analysis evaluated if differences are within the limits of agreement.