OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier

Running, not enrolling · Not applicable

Conditions studied: Nonterminal Premolar Needing Extraction

In brief

The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.

Key facts

Study ID

NCT06447844

Run by

McGuire Institute

People needed

70

Starts

2024-03-28

Expected to finish

2027-11-28

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• McClain and Schallhorn Periodontics and Implant Dentistry — Aurora, Colorado, United States
• Colorado Gum Care — Broomfield, Colorado, United States
• The Perio Studio — Boston, Massachusetts, United States
• Seven Lakes Periodontics — Fenton, Michigan, United States
• Metro West Orthodontics and Periodontics — La Vista, Nebraska, United States
• Perio & Implant Associates of Middle TN — Nashville, Tennessee, United States
• Perio Health Professionals — Houston, Texas, United States
• Gulf Coast Periodontics — Victoria, Texas, United States
• WisNova Institute of Dental Specialists — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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