Malocclusion, Orthodontic Anchorage Procedures, Orthodontics
Conditions
Keywords
miniscrews, computer guided surgery, TADs, orthodontics
Brief 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.
Interventions
PROCEDUREComputer-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.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This investigation is designed as an interventional, parallel-cohort randomized clinical study aimed at comparing two computer-assisted surgical approaches for palatal paramedian orthodontic miniscrew placement. Eligible participants are prospectively enrolled and are allocated in a 1:1 ratio to one of two parallel intervention cohorts: static computer-assisted surgery (s-CAS) or dynamic computer-assisted surgery (d-CAS). Randomization is performed at the participant level, and each subject receives only one type of intervention, with no crossover between cohorts.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apical deviation | Perioperative/Periprocedural | The linear deviation at the apical endpoint of the miniscrew (in millimeters) |
| Coronal deviation | Perioperative/Periprocedural | The linear deviation at the coronal entry point of the miniscrew (in millimeters) |
| Depth deviation | Perioperative/Periprocedural | quantifies the vertical displacement of the apical tip (in millimeters) |
| angular deviation | Perioperative/Periprocedural | the angular difference between the planned and actual screw trajectories (in angular degrees) |
Countries
Italy
Outcome results
None listed