A custom-shaped healing cap may keep gums and bone in better shape after tooth extraction and implant placement
NCT ID NCT07727980
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
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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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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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
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20 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Indiana University School of Dentistry
Indianapolis, Indiana, 46202, United States
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University of Illinois Chicago College of Dentistry
Chicago, Illinois, 60612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Drilling through roots: a new path to steadier dental implants?
- Can leaving a sliver of tooth root save your smile after an implant?
- Can a tiny incision make dental implant surgery less painful?
- The tiny implant part that could save your jawbone
- The race to save jawbone: four socket techniques go head to head
- Can a custom healing cap preserve gum and bone after tooth extraction?