Comparing OsteoGen Plug to Freeze-dried Bone Allograft for Tooth Extraction Sites
OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial
This study is testing whether a new product called OsteoGen® Plug works better than freeze-dried bone for helping patients keep their jawbone healthy after having a tooth pulled.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | McGuire Institute Industry-sponsored |
| Locations | 8 sites (Aurora, Colorado and 7 other locations) |
| Trial ID | NCT06447844 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-site, randomized, controlled trial that compares the effectiveness of OsteoGen® Plug against Freeze-dried Bone Allograft with a collagen barrier for alveolar ridge preservation in patients needing extraction of nonterminal premolars. After tooth extraction, participants will receive either the test or control product, followed by a series of follow-up assessments over a period of 120 days to evaluate oral health outcomes, patient-reported outcomes, adverse events, and complications. The study aims to determine which method better preserves the alveolar ridge for future dental implant placement.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a nonterminal premolar requiring extraction and intact buccal cortical plates.
Not a fit: Patients with untreated active periodontal disease or allergies to the study products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients undergoing tooth extraction and subsequent dental implant placement by enhancing alveolar ridge preservation.
How similar studies have performed: Previous studies have shown promising results with similar approaches in alveolar ridge preservation, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado and 7 other locations
- McClain and Schallhorn Periodontics and Implant Dentistry — Aurora, Colorado, United States (Recruiting)
- Colorado Gum Care — Broomfield, Colorado, United States (Recruiting)
- The Perio Studio — Boston, Massachusetts, United States (Recruiting)
- Seven Lakes Periodontics — Fenton, Michigan, United States (Recruiting)
- Perio & Implant Associates of Middle TN — Nashville, Tennessee, United States (Recruiting)
- Perio Health Professionals — Houston, Texas, United States (Recruiting)
- Gulf Coast Periodontics — Victoria, Texas, United States (Recruiting)
- WisNova Institute of Dental Specialists — Kenosha, Wisconsin, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.