Active, not recruiting
Not applicable
OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier
Condition(s) studied
Nonterminal Premolar Needing Extraction
Investigational drug(s) / intervention(s)
OsteoGen PlugBioGide
OsteoGen Plug: OsteoGen® Plug is contoured to fill the three roots of the socket. Plug is delivered dry into a thoroughly debrided and actively bleeding socket. The OsteoGen® Plug is condensed firmly into the socket.
BioGide: BioGide is a resorbable collagen membrane
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- New bone formation — 120 days
new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120
Trial sites (9)
| Facility | City | Region | Status |
| McClain and Schallhorn Periodontics and Implant Dentistry |
Aurora |
Colorado |
|
| Colorado Gum Care |
Broomfield |
Colorado |
|
| The Perio Studio |
Boston |
Massachusetts |
|
| Seven Lakes Periodontics |
Fenton |
Michigan |
|
| Metro West Orthodontics and Periodontics |
La Vista |
Nebraska |
|
| Perio & Implant Associates of Middle TN |
Nashville |
Tennessee |
|
| Perio Health Professionals |
Houston |
Texas |
|
| Gulf Coast Periodontics |
Victoria |
Texas |
|
| WisNova Institute of Dental Specialists |
Kenosha |
Wisconsin |
|
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