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This randomized split-mouth clinical trial aims to compare the accuracy and clinical outcomes of CAD/CAM 3D-printed surgical guides with the conventional free-hand technique for orthodontic miniscrew placement in the posterior maxilla. Each participant will receive miniscrew placement using both techniques on opposite sides of the maxilla following random allocation. The primary outcome is placement accuracy assessed by three-dimensional positional and angular deviations between planned and actual miniscrew positions. Secondary outcomes include miniscrew stability, success rate after three months, postoperative pain, procedural time, patient satisfaction, and complications. The study also evaluates maxillary posterior cortical bone thickness using cone-beam computed tomography (CBCT) and investigates its relationship with miniscrew placement accuracy and stability
Orthodontic miniscrews have become an effective source of temporary skeletal anchorage because they provide absolute anchorage with minimal dependence on patient compliance. However, the success of orthodontic miniscrews largely depends on accurate insertion while avoiding adjacent anatomical structures, particularly dental roots and the maxillary sinus. Incorrect placement may lead to root damage, instability, or failure of the miniscrew Cone-beam computed tomography (CBCT) allows three-dimensional evaluation of alveolar bone morphology and cortical bone thickness before miniscrew insertion. Digital technologies combining CBCT, intraoral scanning, CAD/CAM planning, and three-dimensional printing have enabled fabrication of customized surgical guides designed to improve insertion accuracy This study is designed as a randomized split-mouth controlled clinical trial. Patients requiring bilateral orthodontic miniscrews in the posterior maxilla will receive one miniscrew inserted using a CAD/CAM 3D-printed surgical guide and the contralateral miniscrew inserted using the conventional free-hand technique. The side allocated to each intervention and the order of insertion will be randomized Placement accuracy will be evaluated by superimposing preoperative planning data with postoperative digital models using Geomagic Studio software. Three-dimensional deviations, including coronal and apical positional deviations and angular deviations, will be calculated. Miniscrew stability, success rate after three months, postoperative pain measured by the Visual Analog Scale (VAS), patient satisfaction, operative time, and treatment-related complications will also be evaluated. Additionally, CBCT will be used to measure cortical bone thickness at multiple posterior maxillary interradicular sites, and correlations between cortical bone thickness and miniscrew accuracy and stability will be analyzed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM-Guided Miniscrew Placement | Experimental | Miniscrew placement using a customized CAD/CAM 3D-printed surgical guide. |
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| Free-Hand Miniscrew Placement | Active Comparator | Conventional free-hand orthodontic miniscrew placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD/CAM 3D-Printed Surgical Guide | Device | A customized tooth-supported CAD/CAM-designed and 3D-printed surgical guide fabricated from CBCT and intraoral scan data to assist accurate orthodontic miniscrew insertion in the posterior maxilla according to the preoperative digital treatment plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Orthodontic Miniscrew Placement | Placement accuracy will be assessed by comparing the planned and actual miniscrew positions using digital superimposition. Coronal and apical three-dimensional deviations together with angular deviations will be calculated using Geomagic Studio software. | Immediately after miniscrew placement |
| Measure | Description | Time Frame |
|---|---|---|
| Miniscrew Success Rate | Clinical success defined as stable miniscrews remaining functional for orthodontic anchorage. | 3 months |
| Miniscrew Stability | Clinical assessment of miniscrew stability after insertion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lam Nguyen Le, Assoc. Prof. | Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Can Tho University of Medicine and Pharmacy | Can Tho | +84 | Vietnam |
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| Free-Hand Orthodontic Miniscrew Placement | Procedure | Orthodontic miniscrews are inserted manually using the conventional free-hand technique without the assistance of a surgical guide, based on the clinician's clinical judgment and anatomical landmarks. |
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| Immediately after insertion, 1 week, 1 month, and 3 months. |
| Three-Dimensional Miniscrew Displacement | Changes in miniscrew position between immediate postoperative and 3-month evaluations | 3 months. |