Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides

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

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Device: CAD/CAM 3D-Printed Surgical Guide; Procedure: Free-Hand Orthodontic Miniscrew Placement

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Can Tho, Vietnam, +84
    • Can Tho University of Medicine and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18 years or older.
• Patients requiring bilateral orthodontic miniscrew placement in the posterior maxilla as part of orthodontic treatment.
• Availability of high-quality cone-beam computed tomography (CBCT) images suitable for evaluation and digital planning.
• Good general health and ability to undergo orthodontic treatment.
• Healthy periodontal tissues at the planned miniscrew insertion sites.
• Ability and willingness to provide written informed consent.

Exclusion Criteria:

• Systemic diseases or medications affecting bone healing or bone metabolism.
• Bleeding disorders or contraindications to minor oral surgery.
• Active periodontal disease or local infection at the planned insertion site.
• Poor-quality or incomplete CBCT images.
• Contraindications to CBCT imaging.
• Pregnancy or lactation.
• Previous orthodontic miniscrew placement in the planned insertion area.
• Refusal or inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAD/CAM-Guided Miniscrew Placement; Miniscrew placement using a customized CAD/CAM 3D-printed surgical guide.	Device: CAD/CAM 3D-Printed Surgical Guide; 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.
Active Comparator: Free-Hand Miniscrew Placement; Conventional free-hand orthodontic miniscrew placement.	Procedure: Free-Hand Orthodontic Miniscrew Placement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Can Tho University of Medicine and Pharmacy
• Investigators: Principal Investigator: Lam Nguyen Le, Assoc. Prof., Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: 3D Printing; CBCT; Surgical Guide; Orthodontic Miniscrew
• Other Study ID Numbers: LeNguyenLam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No