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A custom-shaped healing cap may keep gums and bone in better shape after tooth extraction and implant placement

NCT ID NCT07727980

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests whether an anatomical prefabricated healing abutment (AHA) — a healing cap shaped like a natural tooth — preserves soft tissue and bone better than a standard cylindrical one after immediate implant placement. Adults needing a hopeless molar extracted and an implant placed right away will receive either the AHA or a conventional abutment. Researchers will track changes in gum contours, bone levels, and implant stability over 12 months using scans and X-rays to see which approach maintains a more natural look and function.

What this could mean

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

Active substance
an anatomical prefabricated healing abutment (AHA), a dental implant component designed to mimic the natural tooth shape and support healing tissues
What this could lead to
If it works, this could lead to better-looking and more stable dental implants by preserving the natural gum and bone contours after tooth extraction.
What could go wrong
This is a small, early-stage trial with only 30 participants, so results may not apply to everyone. The new abutment might not improve outcomes over the standard one and could carry similar risks of 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 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 to 75 years

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: * Willing to sign an IRB-approved informed consent and HIPAA authorization form prior to participation. * Between the ages of 20 and 75 years old. * ASA Classification I and II. * Hopeless maxillary or mandibular posterior teeth, eligible for immediate implantation, and with intact/successfully restored adjacent teeth. * Willing to perform tasks associated with the study and to attend all study visits. Exclusion Criteria: * HbA1c \>6.5%) as per a chairside test (Siemens Bayer DCA 2000+); * smoker (any status); * immunodeficiency; * history of head and neck radiotherapy; * intake of bone anti-resorptive drugs; * cysts or tumors in the area; * self-reported pregnancy; * poor oral hygiene; * active periodontal disease; * acute endodontic infection and pus discharge on the site itself and adjacent areas; * lack of mutually protected occlusion; * insufficient inter-occlusal clearance (\<15 mm); * sites with an existing midfacial mucogingival recession/deficiency (scar tissue); * sites with a high-scalloped, thin biotype. Those who appear to qualify will have a CBCT scan taken with an open bite and proper retractions of the cheek, lips, and tongue (standard of care), and the following inclusion criteria, based on the CBCT results, must be present in order for the subject to be fully enrolled in the study: * Sites with an intact or minimally damaged facial bone plate measuring greater than 1 mm in thickness; * Sites with at least 5 mm of healthy bone between the socket apex and the relevant anatomical structure (e.g., the maxillary sinus floor in the maxilla or the inferior alveolar nerve, submandibular/sublingual fossa, mental foramen, or anterior loop of the inferior alveolar nerve in the mandible); * In multirooted molar sockets, the presence of a short root trunk and an interradicular septum with a minimum height of 5 mm and a thickness of 3 mm.

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Conditions

The condition(s) this trial relates to.

Tooth Loss

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

  • Indiana University School of Dentistry

    Indianapolis, Indiana, 46202, United States

  • University of Illinois Chicago College of Dentistry

    Chicago, Illinois, 60612, United States

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