Evaluation of the Accuracy of Palatal Orthodontic Miniscrew Placement.

University of Roma La Sapienza

Status: Completed

Conditions: Orthodontic Anchorage Procedures; Orthodontics; Malocclusion

Treatments: Procedure: Computer-guided Miniscrew insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT07378618

URomLS_StaticVsDynamic

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Static computer-guided surgery group

Active Comparator group

Description:

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.

Treatment:

Procedure: Computer-guided Miniscrew insertion

Dynamic computer-guided surgery

Experimental group

Description:

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

Treatment:

Procedure: Computer-guided Miniscrew insertion