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

After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.

OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.

Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.

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.