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Custom jaw implants put to the test: will they improve surgery precision?

NCT ID NCT07222904

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at how accurately a custom-made implant (called a PSI) could reposition the lower jaw during surgery for overbite or underbite. Eight patients aged 18-40 who needed jaw surgery received the custom implant. The researchers compared the planned jaw position with the actual result using CT scans. The goal was to see if the custom implant leads to more precise alignment.

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 Implant (PSI) - a custom-made device used to fix the jaw after surgical repositioning
What this could lead to
If successful, this could show that custom implants improve the precision of jaw alignment surgery, potentially leading to better outcomes and fewer adjustments.
What could go wrong
This was a very small study (8 people) and only measured accuracy, not long-term outcomes or safety. The results may not apply to all patients or surgeons.

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

8 people

The number who actually took part.

Started

Jan 2023

Finished

May 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 40 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: 1. Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent. 2. Patients with skeletal class II or class III who are in need of mandibular orthognathic surgery. Exclusion Criteria: 1. Patients who had previous orthognathic surgery. 2. Patients with previous severe facial trauma history or fracture mandible. 3. Patients with congenital facial asymmetry. 4. Patients with systemic diseases and immunocompromised patient.

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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.

Contacts and locations

Locations

  • Eman Ashour

    Cairo, 12345, Egypt

More trials for these conditions

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