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Dental implant dilemma: to keep or remove when jaw bone dies?

NCT ID NCT07435259

Knowledge-focused Sponsor: Kyunghee University Dental Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study looks at patients who develop a condition called MRONJ (bone death in the jaw) after taking osteoporosis medications. When this happens around a dental implant, doctors disagree on whether to remove the implant or try to save it. The study will compare healing and bone changes in 50 patients over one year, using the amount of bone loss around the implant (20-60%) as a guide for treatment choice.

What this could mean

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

What this could lead to
If successful, this study could provide clear guidelines for dentists on whether to keep or remove implants in patients with medication-related jaw bone damage.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The best approach may still depend on individual cases.

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 50 people

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

Started

Apr 2026

Expected to finish

Jun 2028

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

20 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 diagnosed with medication-related osteonecrosis of the jaw (MRONJ) (AAOMS stage 0, 1, or 2) who have been treated with antiresorptive agents (e.g., bisphosphonates or denosumab) and/or selective estrogen receptor modulators (SERMs). * Presence of an MRONJ lesion involving at least one dental implant at the affected site. * Radiographic peri-implant bone loss between ≥20% and \<60% of the implant length at the most severe area on baseline imaging. * No implant mobility. * Able and willing to provide written informed consent after receiving an adequate explanation of the study purpose and procedures. Exclusion Criteria: * History of radiotherapy to the head and neck region. * Presence of metastatic disease or bone diseases such as multiple myeloma or Paget's disease of the jaw. * Current treatment with anti-angiogenic agents (e.g., bevacizumab, ranibizumab, lenalidomide, sunitinib) or immunomodulatory agents (e.g., methotrexate) for cancer therapy. * Uncontrolled systemic disease that may contraindicate surgery or impair healing (e.g., uncontrolled diabetes, recent chemotherapy, severe immunosuppression). * Refusal of treatment or follow-up, withdrawal of consent, or inability to comply with study procedures. * Peri-implant bone loss outside the predefined range (\<20% or ≥60%) on preoperative imaging or intraoperative assessment.

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Conditions

The condition(s) this trial relates to.

osteonecrosis of the jaw osteoporosis

As listed by the trial registrant

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

Medication-related osteonecrosis of the jaw

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

  • Kyung Hee University Dental Hospital

    RECRUITING

    Seoul, Seoul, 02447, South Korea

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