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New bone plug aims to simplify dental implant prep

NCT ID NCT06447844

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a synthetic bone plug (OsteoGen Plug) to a standard freeze-dried bone graft with a collagen membrane for preserving the jawbone after a premolar is pulled. Seventy adults needing a tooth extraction and later a dental implant will be randomly assigned to one of the two treatments. The main goal is to see how much new bone forms by 120 days, using 3D X-rays.

What this could mean

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

Active substance
OsteoGen Plug (a synthetic bone graft device) and freeze-dried bone allograft with collagen barrier
What this could lead to
If successful, this could offer a simpler, effective option for preserving jawbone after tooth extraction, potentially improving dental implant outcomes.
What could go wrong
This is a small, early-stage trial (70 people) comparing two existing methods, so results may not apply broadly. The main risk is that the new plug may not preserve bone as well as the standard graft.

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 70 people

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

Started

Mar 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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: * Subjects 18 to 75-yrs of age. * Subjects with a nonterminal premolar in need of extraction with intention to pursue implant replacement. * Proposed treatment site must have intact buccal cortical plates \> 1 mm in thickness (buccal bone dehiscence up to 25% root length is permissible). Apical lesions are acceptable which do not perforate the cortical plate). * Proposed treatment site must have intact adjacent natural teeth. (no adjacent edentulous sites or implants). * Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures. * Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF). * Subjects must be able and willing to follow study procedures and instructions. Exclusion Criteria: * Subjects with reported allergy or hypersensitivity to any of the products to be used in the study. * Subjects with untreated / active periodontal disease. * Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions. * Tobacco/Cannabis users including cigarettes, vape, cigars, or smokeless tobacco. * Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer) * Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration. * Subjects who would require a tissue supported interim prosthesis i.e. acrylic / valplast RPD (tooth supported interim prostheses i.e. essix retainers are acceptable) * Subjects with long-term history of oral bisphosphonates (\> 10 years). * Subjects with a history of intravenous bisphosphonates. * Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia) * Subjects taking corticosteroids or immunosuppressants on a regular basis prior to baseline examination. * Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis who are not medically cleared to hold medication prior to and during procedure. * Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). * Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Colorado Gum Care

    Broomfield, Colorado, 80020, United States

  • Gulf Coast Periodontics

    Victoria, Texas, 77904, United States

  • McClain and Schallhorn Periodontics and Implant Dentistry

    Aurora, Colorado, 80012-3260, United States

  • Metro West Orthodontics and Periodontics

    La Vista, Nebraska, 68128, United States

  • Perio & Implant Associates of Middle TN

    Nashville, Tennessee, 37215, United States

  • Perio Health Professionals

    Houston, Texas, 77063-7229, United States

  • Seven Lakes Periodontics

    Fenton, Michigan, 48430, United States

  • The Perio Studio

    Boston, Massachusetts, 02108, United States

  • WisNova Institute of Dental Specialists

    Kenosha, Wisconsin, 53144-4292, United States