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New bone graft could help dental implant patients with jawbone loss

NCT ID NCT06533397

Disease control Sponsor: Semmelweis University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a synthetic bone graft material (biphasic calcium sulfate) used during sinus lift surgery to rebuild bone in the upper jaw. The goal is to see if it safely creates enough bone to place dental implants in people who lack sufficient bone due to sinus expansion. Forty adults needing implants will be followed for up to 6 months to check bone growth and implant success.

What this could mean

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

Active substance
biphasic calcium sulfate (Bond Apatite) synthetic bone graft
What this could lead to
If successful, this could provide a safe and effective option for rebuilding jawbone to support dental implants in people with bone loss in the upper jaw.
What could go wrong
This is a small, early-stage study with only 40 participants and no comparison group. The graft may not integrate well or could cause complications like infection or implant failure.

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 40 people

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

Started

Aug 2024

Expected to finish

Sep 2031

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: * Patients over the age of 18 years, * Patients who need dental implant-borne prostheses, * Patients with insufficient bone height in the posterior maxilla due to sinus pneumatization. Exclusion criteria: .• Patients who had major systemic diseases as classified by the American Society of Anesthesiologists (ASA grades III-IV), * psychiatric contraindications, * patients on medication interfering with bone metabolism, including steroid therapy and antiresorptive medication, * radiation to the head or neck region within the previous five years, * localized periapical disease, odontogenic and nonodontogenic cysts, and maxillary sinusitis, * evidence of uncontrolled periodontal disease, * Alcohol Use Disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), * recreational drug abuse, * heavy smoking (\>10 cigarettes/day), * diseases of the oral mucosa, including blisters and ulcers, i.e.: red and white lesions, pigmented lesions, benign tumors of the oral cavity, and oral cancer. Leukoplakia, Erythroplakia, Precancerous lesions, Oral squamous cell carcinoma and malign tumors of the soft and hard tissues, Oral candidiasis, Oral lichen planus, Psoriasis, Pemphigus, and Pemphigoid. * pregnancy or nursing, * poor oral hygiene

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Conditions

The condition(s) this trial relates to.

Alveolar Bone Loss periodontal disorder

As listed by the trial registrant

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

Alveolar bone loss Edentulism nos

How to take part

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

  1. The places running it

    1 site. 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

  • Semmelweis University Department of Public Dental Health

    RECRUITING

    Budapest, Budapest, 1088, Hungary

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