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New study tests if dentures can be attached to implants right away

NCT ID NCT06038487

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study compares two ways of attaching a full upper denture to dental implants: attaching it right after implant surgery (immediate loading) versus waiting 3 months (delayed loading). Researchers will track bone loss, gum health, and patient satisfaction over 3 years. The study involves 18 adults with no upper teeth who already wear a complete denture.

What this could mean

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

Active substance
dental implant loading procedure
What this could lead to
If immediate loading works as well as delayed, patients could get their dentures attached sooner, reducing wait time and improving convenience.
What could go wrong
This is a small, early-stage study with only 18 participants, so results may not apply to everyone. Immediate loading might increase risk of implant failure or bone loss.

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 18 people

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

Started

Feb 2023

Expected to finish

Feb 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

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Males and females must be at least ≥ 21 years of age 2. Fully edentulous maxilla 3. The implant site has to be healed for at least 4 months after extraction 4. Wearing complete dentures deemed adequate 5. Orthopantomogram available (OPT) 6. Adequate amount of bone at least at the 2nd premolar position to house at minimum a 3.5 x 10 mm BLX-Roxolid implant 7. No bone grafting required 8. Implant IT ≥ 20 N/cm Exclusion Criteria: 1. Conditions requiring chronic routine prophylactic use of antibiotics 2. Conditions requiring prolonged use of steroids 3. History of leukocyte dysfunction and deficiencies 4. Bleeding disorders 5. History of neoplastic disease requiring use of radiation or chemotherapy 6. Metabolic bone disorders 7. Uncontrolled endocrine disorder 8. Use of any investigational drug or device within the 30-day period prior to implant surgery 9. Vaping, Tobacco Chewing or Smoking more than 10 cigarettes a day 10. Alcoholism or drug abuse 11. Patient infected with HIV 12. Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as as history of non-compliance, unreliability. 13. Local inflammation including untreated periodontitis 14. Mucosal disease such as erosive lichen planus 15. History of local irradiation therapy 16. Osseous lesion 17. Severe bruxism and clenching habits 18. Active infection with suppuration or fistula track 19. Persistent intraoral infection 20. Lack of primary stability \<20Ncm. In this instance, the patient must be withdrawn and treated according to the standard protocol. 21. Inadequate oral hygiene or unmotivated home care. 22. Bone grafting needed 23. Inadequate bone volume for implants insertion as measured on the pre-treatment cone beam computed tomography (CBCT).

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As listed by the trial registrant

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

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. 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

  • Case Western Reserve University Department of Periodontics

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26505, United States

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