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Jaw implants aim to boost life quality after surgery

NCT ID NCT05271383

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at how well Global D implants work for orthognathic (jaw) surgery and whether they improve patients' quality of life. 198 people who had their first jaw surgery received these implants. Researchers measured quality of life before and after surgery using a special questionnaire, and checked bone healing at 6 weeks. The goal was to confirm the implants are safe and effective.

What this could mean

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

Active substance
Global D implants (ORTRAUTEK® and MINITEK®) used in orthognathic surgery
What this could lead to
If successful, this could confirm that these implants improve quality of life and are safe for people needing jaw realignment surgery.
What could go wrong
This is a completed study, but results are not yet published. The study only measures short-term outcomes (6 weeks), so long-term benefits or risks remain unknown.

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.

Participants

198 people

The number who actually took part.

Started

Feb 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population is composed of male and female, major or minor, who will be treated by orthognatic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty). The bone maturity of the participants (assessed by investigators) need to be sufficient for the treatment.

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: * Male or female patient, major or minor, having reached bone maturity according to the judgement of the investigator, * Patient having first orthognathic surgery (maxillary, mandibular, maxillomandibular or/with genioplasty) * Patient who received orthodontic treatment prior to orthognathic surgery. * Patient with abilities to read, understand and answer to the study quality of life questionnaire. * Patient (and his legal representative if minor) who signed the study consent form. * Patient affiliated to a social security system. Exclusion Criteria: * Patient allergic to one of the components of the implants * Patient with physical or mental inabilities that will compromise the follow-up during the study * Patient with acute or chronic infection (local or systemic) * Person on legal protection * Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

disorder of facial skeleton jaw fracture Maxillary Fractures Maxillofacial Abnormalities

As listed by the trial registrant

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

Maxilla fracture Maxillofacial abnormalities Orthognathic surgery

Contacts and locations

Locations

  • CHU de Nantes

    Nantes, 44000, France

More trials for these conditions

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