New bone plug aims to simplify dental implant prep
NCT ID NCT06447844
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
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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 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 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: * 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
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Colorado Gum Care
Broomfield, Colorado, 80020, United States
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Gulf Coast Periodontics
Victoria, Texas, 77904, United States
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McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado, 80012-3260, United States
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Metro West Orthodontics and Periodontics
La Vista, Nebraska, 68128, United States
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Perio & Implant Associates of Middle TN
Nashville, Tennessee, 37215, United States
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Perio Health Professionals
Houston, Texas, 77063-7229, United States
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Seven Lakes Periodontics
Fenton, Michigan, 48430, United States
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The Perio Studio
Boston, Massachusetts, 02108, United States
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WisNova Institute of Dental Specialists
Kenosha, Wisconsin, 53144-4292, United States