Evaluation of Maxillary Buccal Miniscrew Insertion Using Digital Guides

NCT07698730 | Completed

• 1 other identifier: LeNguyenLam
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthodontic Appliance Complication

Keywords

Orthodontic Miniscrew; 3D Printing; CBCT; Surgical Guide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Miniscrew Success Rate

  3 months

• Miniscrew Stability

  Immediately after insertion, 1 week, 1 month, and 3 months.

• Three-Dimensional Miniscrew Displacement

  3 months.

Study Arms (2)

CAD/CAM-Guided Miniscrew Placement

EXPERIMENTAL

Miniscrew placement using a customized CAD/CAM 3D-printed surgical guide.

Device: CAD/CAM 3D-Printed Surgical Guide

Free-Hand Miniscrew Placement

ACTIVE COMPARATOR

Conventional free-hand orthodontic miniscrew placement.

Procedure: Free-Hand Orthodontic Miniscrew Placement

Interventions

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.

CAD/CAM-Guided Miniscrew Placement

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.

Free-Hand Miniscrew Placement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, +84, Vietnam

Location

Study Officials

• Lam Nguyen Le, Assoc. Prof.

  Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: November 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

VN (1)