Evaluation of the Accuracy of Palatal Orthodontic Miniscrew Placement.

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.

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Key information

Conditions

Malocclusion Orthodontic Anchorage Procedures Orthodontics Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Roma, 00161, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer-guided Miniscrew insertion

Procedure

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.

Primary outcomes

Apical deviation

Time frame: Perioperative/Periprocedural

The linear deviation at the apical endpoint of the miniscrew (in millimeters)
Coronal deviation

Time frame: Perioperative/Periprocedural

The linear deviation at the coronal entry point of the miniscrew (in millimeters)
Depth deviation

Time frame: Perioperative/Periprocedural

quantifies the vertical displacement of the apical tip (in millimeters)
angular deviation

Time frame: Perioperative/Periprocedural

the angular difference between the planned and actual screw trajectories (in angular degrees)

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Jan 30, 2026
Registry last updated: Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed