NCT07378618

Evaluation of the Accuracy of Palatal Orthodontic Miniscrew Placement.

Accuracy of Palatal Orthodontic Miniscrew Placement: Static vs Dynamic Computer-Guided Techniques in a Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This randomized clinical trial has the objective of comparing the accuracy of palatal paramedian miniscrew placement using static computer-assisted surgery (s-CAS) and dynamic computer-assisted surgery (d-CAS). A population of forty subjects requiring palatal paramedian miniscrew insertion is going to be randomized into two groups to receive two miniscrews placed with s-CAS (Group A; n=20 subjects, 40 miniscrews) and d-CAS (Group B; n=20 subjects, 40 miniscrews). Preoperative digital intraoral scans and CBCT images will be used for virtual planning. Group A procedures is going to employ patient-specific surgical guides, while group B procedures is going to be performed with real-time navigation. Immediate postoperative CBCT scans will be superimposed to measure four accuracy parameters: coronal, apical, depth, and angular deviation from the planned position. Statistical analysis will include Student's t-test or Mann-Whitney U test as appropriate.

Conditions

• Malocclusion
• Orthodontic Anchorage Procedures
• Orthodontics

Interventions

Type	Name	Description
PROCEDURE	Computer-guided Miniscrew insertion	This intervention consists of a standardized digital workflow for orthodontic miniscrew placement in the paramedian region of the maxillary palate. Based on this integrated dataset, miniscrew position, angulation, and insertion depth are virtually planned to achieve bicortical anchorage while respecting predefined safety margins. Miniscrew insertion is performed under local anesthesia using self-drilling orthodontic miniscrews of standardized dimensions, without pre-drilling. Depending on group allocation, placement is carried out using either a static surgical guide or real-time dynamic navigation, while imaging acquisition and planning protocols remain identical. Immediate postoperative CBCT imaging is obtained to verify miniscrew position and to allow quantitative accuracy assessment.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-09-01
• Completion: 2026-01-10
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: Italy