Failure Rate of Orthodontic Mini-screw after Insertion using 3D Printed Guide versus Conventional Free Hand Placement Technique: Split Mouth Randomized Clinical Trial

AIM: The aim of the study is to assess the failure rate after mini-screw insertion using digital three-dimensional printed guide versus free hand placement technique through a well-designed split-mouth randomized clinical trial. METHODS: Forty-two patients with mean age (22.56 ± 3.47 years) indicated for upper first premolars’ extraction (Bimaxillary protrusion and Class II division 1) were included in the study. Their maxillary quadrants were randomized to receive mini-screws as means of anchorage. Pre-operative maxillary cone-beam computed tomography scan with ultra-low-dose protocol was imaged and the maxillary arch was scanned using intra-oral scanner to obtain stereo-lithographic format file for the maxillary arch. Using in vivo and Rapidform Geomagic Studio® _Softwares the mini-screws were planned to be inserted in the buccal inter-radicular space between the upper second premolar and first molar in both right and left sides. For the intervention sides; digital three-dimensional guides were designed and printed for mini-screw insertion. Failure of the mini-screws was assessed till 3 months of loading. RESULTS: There was no statistical significant difference in failure rate of mini-screws in both intervention (7.14%) and control sides (16.6%), with weak and moderate correlation between the root proximity and the mini-screws failure in intervention and control groups respectively. CONCLUSIONS: Using a digital three-dimensional printed guide for mini-screw insertion had no effect on the failure rate of the inserted mini-screws. REGISTRATION: ClinicalTrials.gov Identifier: NCT03653078.