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New implant study aims to restore smiles for those with severe jaw bone loss

NCT ID NCT07258940

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a special dental implant system for people whose upper jaw has lost too much bone for regular implants. About 85 adults will receive the implants and be followed for 12 months to check for sinus infections, implant success, and how satisfied they are with the results. The goal is to see if this approach is safe and effective for restoring teeth.

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 85 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

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.

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: * Participant has signed the informed consent form (ICF). * Participant aged ≥ 18 years at the time of treatment. * Medical and anatomical conditions are in accordance with the applicable IFU. * Participant with a severely atrophic maxilla classified as Cawood and Howell class V or VI * Suitable for immediate loading. Exclusion Criteria: * Presence of acute or chronic maxillary sinusitis. * Zygomatic bone pathologies including tumors, infections, or congenital abnormalities * History of recurrent sinusitis (≥ 4 occurrences/year) * Pre-operative LM score of ≥ 1 * Uncontrolled systemic disorders including poorly controlled hypertension, uncontrolled diabetes, cardiovascular disease. * Active malignancy or currently undergoing oncological treatment. * History of severe maxillary jaw injury or maxillofacial trauma. * Moderate and heavy smokers (defined as \> 5 cigarettes a day). * Severe bruxism or dysfunctional tendencies * Previous oro-maxillofacial radiotherapy. * Use of bisphosphonates. * Pregnant or lactating women * Implant loaded \> 1 week of zygomatic implant placement

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Conditions

The condition(s) this trial relates to.

Atrophic Maxilla

As listed by the trial registrant

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

Atrophic maxilla Edentulous maxilla Maxillary bone loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hirslanden Medical Center

    Aarau, 5000, Switzerland

  • Universitiy of Verona, Unit of Stomatology and Maxillo-Facial Surgery

    Verona, 37134, Italy

More trials for these conditions

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