A gum graft over a bone graft: could it make dental implants last longer?

NCT ID NCT07082244

Disease control Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether adding a soft tissue graft substitute over a bone graft improves the health, appearance, and stability of the bone and gums around a single dental implant. Participants have a missing tooth with bone loss and will receive either a collagen membrane or an acellular dermal matrix over the bone graft during implant placement. The study measures changes in bone level, gum shape, and blood flow over time.

What this could mean

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

Active substance: guided bone regeneration with collagen membrane or acellular dermal matrix, plus dental implant placement
What this could lead to: If it works, this could lead to a standard technique that improves the long-term health and appearance of dental implants in people with bone loss.
What could go wrong: This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The added soft tissue graft may not provide significant benefit over bone grafting alone.

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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

Jun 2025

Expected to finish

Sep 2027

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: * Age ≥ 18 years. * Subjects with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of Anesthesiology (ASA) I or II. * Subjects must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and canine region of the mandible. This region includes the maxillary premolars, canines, and incisors. * Subjects must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth. * The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm. * Seibert class I deficiency (Seibert, 1983) * Patients willing to sign the informed consent. Exclusion Criteria: * Presence of uncontrolled and/or untreated periodontal disease. * Patients currently smoking cigarettes, cannabis, and electronic cigarettes. * Subjects taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates, corticosteroids, parathyroid hormone, RANKL inhibitors, past exposure to head and neck radiation, chemotherapy within the last 12 months, among others. * Subjects with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease. * Allergy to the graft materials. * Pregnant subjects or individuals who self-report as attempting to become pregnant. * Patient's unwilling to sign the informed consent.

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As listed by the trial registrant

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

Horizontal ridge deficiency

How to take part

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

The places running it

1 site. The list below names each one and where it is.
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

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A gum graft over a bone graft: could it make dental implants last longer?

What the study statuses mean