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Custom 3D-Printed jaw implants put to the test against traditional surgery

NCT ID NCT06297109

Disease control Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two standard ways to fix jaw position after surgery: custom 3D-printed titanium implants (PSIs) versus traditional metal plates that surgeons bend during the operation. Researchers will check how accurately the bones are placed right after surgery and how stable they remain two years later. Sixty patients with overjet or overbite will take part, and the goal is to see if the custom implants lead to more precise and lasting results.

What this could mean

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

Active substance
Patient-specific implants (PSI) and conventional mini-plates
What this could lead to
If PSIs prove more accurate and stable, they could become the preferred method for complex jaw surgeries, improving outcomes and reducing the need for adjustments.
What could go wrong
This is a relatively small trial (60 people) comparing two already-approved methods, so any advantage may be modest. The results may not apply to all jaw surgery patients.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

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

18 years and older

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: * Mandibular retrognathia * Occlusion class II * Three-piece Le Fort I osteotomy, as part of bimaxillary orthognathic surgery with or without genioplasty Exclusion Criteria: * Cleft lip * Craniofacial syndromes * Former trauma * Obstructive sleep apnea

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Conditions

The condition(s) this trial relates to.

isolated Pierre-Robin syndrome malocclusion due to protuberant upper front teeth Malocclusion, Angle Class II Retrognathia

As listed by the trial registrant

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

Malocclusion, angle class II Retrognathia

Contacts and locations

Locations

  • University Hospital of Southern Denmark

    Esbjerg, 6700, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.