Custom 3D-Printed guide aims to improve jaw fracture repair

NCT ID NCT07153354

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study tests whether using a 3D-printed surgical guide and pre-bent metal plates can make jaw fracture surgery more accurate than the standard approach. Twenty adults with a specific type of jaw fracture will be randomly assigned to either the new precision method or the usual surgery. The main goal is to see if the new technique leads to better bone alignment and fewer complications like bite problems or nerve damage.

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 screw holes locating surgical guide and pre-bent plates
What this could lead to
If successful, this could make jaw fracture surgery more precise, reducing complications like misalignment and nerve injury.
What could go wrong
This is a very small early study with only 20 patients, so results may not apply to everyone. The technology may not improve outcomes enough to justify the extra cost and planning time.

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 20 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Oct 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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients with delayed mandibular class IV fracture need open reduction and internal fixation. * Patients with a medical history that did not hinder plate placement (uncontrolled diabetes) and adequate proper oral hygiene. * Both genders, males and females, will be included Exclusion Criteria: * General contraindications to surgery. * Patients with unfavorable or comminuted fractures. * Subjected to irradiation in the head and neck area less than 1 year before fixation. * Poor oral hygiene and motivation. * Uncontrolled diabetes. * Pregnant or nursing. * Substance abuse. * Psychiatric problems or unrealistic expectations. * Severe bruxism or clenching. * Immunosuppressed or immunocompromised. * Treated or under treatment with intravenous amino-bisphosphonates. * Patients participating in other studies, if the present protocol could not be properly followed.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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