MalocclusionNCT07378618
Evaluation of the Accuracy of Palatal Orthodontic Miniscrew Placement.
A study testing Computer-guided Miniscrew insertion in people with Malocclusion and Orthodontic Anchorage Procedures, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Orthodontic Anchorage Procedures, Orthodontics
- What is being tested?
- Computer-guided Miniscrew insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (1) syndromic patients
- (2) uncontrolled systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Malocclusion, Orthodontic Anchorage Procedures, Orthodontics
- Being tested
- Computer-guided Miniscrew insertion
- Keywords
- miniscrews, computer guided surgery, TADs, orthodontics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-guided Miniscrew insertionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Static computer-guided surgery group | Active comparator | 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. Receives: Procedure: Computer-guided Miniscrew insertion |
| Dynamic computer-guided surgery | Experimental | 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 Receives: Procedure: Computer-guided Miniscrew insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apical deviation
The linear deviation at the apical endpoint of the miniscrew (in millimeters)
Measured: Perioperative/Periprocedural
Coronal deviation
The linear deviation at the coronal entry point of the miniscrew (in millimeters)
Measured: Perioperative/Periprocedural
Depth deviation
quantifies the vertical displacement of the apical tip (in millimeters)
Measured: Perioperative/Periprocedural
angular deviation
the angular difference between the planned and actual screw trajectories (in angular degrees)
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Dec 2023
- Primary completion1 Sep 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Cassetta, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378618
- Sponsor's protocol ID
- URomLS_StaticVsDynamic
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brilli D, Giansanti M, Altieri F, Cassetta M. Accuracy of palatal orthodontic miniscrew placement: Static vs dynamic computer-guided techniques in a randomized clinical trial. Clin Oral Investig. 2026 Jun 15;30(7):293. doi: 10.1007/s00784-026-06975-9.
PubMed 42289607
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Palatal Orthodontic Miniscrew Placement: Static vs Dynamic Computer-Guided Techniques in a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07378618
- Acronym / sponsor ID
- URomLS_StaticVsDynamic
- Conditions
- Malocclusion, Orthodontic Anchorage Procedures, Orthodontics
- Keywords
- miniscrews, computer guided surgery, TADs, orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Static computer-guided surgery group | Active comparator | Procedure: Computer-guided Miniscrew insertionParticipants 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. |
| Dynamic computer-guided surgery | Experimental | Procedure: Computer-guided Miniscrew insertionParticipants 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (2 listed)
- (1) syndromic patients
- (2) uncontrolled systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-guided Miniscrew insertionThis 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. | Procedure or surgery | Dynamic computer-guided surgery, Static computer-guided surgery group |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 42289607Brilli D, Giansanti M, Altieri F, Cassetta M. Accuracy of palatal orthodontic miniscrew placement: Static vs dynamic computer-guided techniques in a randomized clinical trial. Clin Oral Investig. 2026 Jun 15;30(7):293. doi: 10.1007/s00784-026-06975-9.
- Individual participant dataSharing planned: No
Related trials for Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-guided Miniscrew insertion in people with Malocclusion and Orthodontic Anchorage Procedures, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apical deviation (time frame: Perioperative/Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07378618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.