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Digital vs. direct: which method places jaw screws more accurately?

NCT ID NCT07707596

Knowledge-focused Sponsor: Universitat Internacional de Catalunya Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This trial compares two methods for placing tiny screws in the roof of the mouth (palatal miniscrews) to help widen the upper jaw in teenagers. One method uses the expansion device itself as a guide, while the other uses a custom 3D-printed guide based on digital planning. The study measures how accurate, stable, and safe each approach is using post-procedure scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a procedure comparing direct appliance-guided versus digitally guided CAD/CAM surgical guide for palatal miniscrew placement
What this could lead to
If one method proves more accurate and safer, it could become the standard approach for palatal miniscrew placement in teens needing jaw expansion.
What could go wrong
This is a small, early-stage study (40 participants) comparing two techniques, so results may not apply to all patients or settings. Both methods carry risks like screw failure or sinus penetration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

May 2025

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 12 and 18 years * Transverse maxillary deficiency requiring skeletal expansion * Midpalatal suture maturation stage B or C * Adequate palatal bone height for miniscrew insertion (≥9 mm) * No previous maxillary expansion treatment Exclusion Criteria: * Age \>18 years * Palatal bone height \<6 mm * Systemic disease affecting bone metabolism * Medication affecting bone turnover * Craniofacial syndromes or cleft conditions

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Maxillary transverse deficiency

Contacts and locations

Locations

  • Universitat Internacional de Catalunya

    Sant Cugat del Vallès, Barcelona, 08017, Spain

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