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.

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion; Orthodontics; Orthodontic Anchorage Procedures
• Intervention / Treatment: Procedure: Computer-guided Miniscrew insertion

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma
    • Roma, Roma, Italy, 00161
      • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• (1) subjects in late mixed dentition or permanent dentition,
• (2) a need for orthodontic or orthopedic treatment and no previous treatments,
• (3) good oral hygiene,
• (4) absence of acute infection in the oral cavity,
• (5) good general health

Exclusion Criteria:

• (1) syndromic patients
• (2) uncontrolled systemic diseases.

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
Active Comparator: Static computer-guided surgery group; Participants allocated to this arm undergo palatal paramedian orthodontic miniscrew placement using a static computer-assisted surgical protocol. Preoperative planning is performed by integrating cone-beam computed tomography (CBCT) data with intraoral digital scans to define the planned miniscrew position, trajectory, and insertion depth. Based on the virtual plan, a patient-specific stereolithographic surgical guide is digitally designed to adapt to the palatal anatomy and to extend to the posterior dentition in order to ensure stability. The surgical guide is fabricated using biocompatible resin through additive manufacturing and will be verified intraorally for proper fit prior to miniscrew insertion. Miniscrew placement is performed under local anesthesia using the static guide, which constrains the insertion path and depth according to the preoperative plan. Two self-drilling orthodontic miniscrews of standardized dimensions are placed in the paramedian palatal region.	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.
Experimental: Dynamic computer-guided surgery; Participants allocated to this arm undergo palatal paramedian orthodontic miniscrew placement using a dynamic computer-assisted navigation system. Preoperative planning is conducted by merging CBCT datasets with intraoral digital scans within a dedicated navigation software environment to define the planned miniscrew position, angulation, and insertion depth. No physical surgical guide is produced for this intervention. Real-time navigation is enabled through the registration of a jaw reference tool and a handpiece tracking system, which allow continuous monitoring of instrument position relative to the patient's anatomy. Miniscrew insertion is performed under local anesthesia while the operator follows real-time visual feedback displayed on the navigation interface, enabling ongoing verification and, when necessary, intraoperative adjustment of the insertion trajectory. Two self-drilling orthodontic miniscrews of standardized dimensions are inserted in the paramedian palatal regio	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apical deviation	The linear deviation at the apical endpoint of the miniscrew (in millimeters)	Perioperative/Periprocedural
Coronal deviation	The linear deviation at the coronal entry point of the miniscrew (in millimeters)	Perioperative/Periprocedural
Depth deviation	quantifies the vertical displacement of the apical tip (in millimeters)	Perioperative/Periprocedural
angular deviation	the angular difference between the planned and actual screw trajectories (in angular degrees)	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): January 10, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: orthodontics; TADs; computer guided surgery; miniscrews
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: URomLS_StaticVsDynamic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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