Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations

Exclusion Criteria16

• Active localized or systemic infection
• Untreated periodontal disease
• Presence of a fenestration larger than 3 mm in diameter in the buccal wall at the time of extraction
• Inadequate bone dimensions or restorative space to place a dental implant
• The subject uses, or has used within 30 45 days of surgery, tobacco or nicotine or is prescribed steroids such as cortisone
• Presence or history of malignancy (excludes surgically resected skin squamous cell or basal cell carcinoma), radiotherapy, or chemotherapy for any malignancy within the last 5 years. History of malignancy may include multiple exostoses syndrome (also known as multiple osteochondromas syndrome), an inherited condition associated with bumps of cartilage on the bones, which has been associated with an increased risk of chondrosarcoma); individuals with hereditary cancer syndromes are excluded. Examples of hereditary cancer syndromes are hereditary breast and ovarian cancer syndrome, Li-Fraumeni syndrome, Cowden syndrome, and Lynch syndrome. Also called family cancer syndrome and inherited cancer syndrome individuals who have undergone any transplant surgery and are on immunosuppressant therapy
• Has a history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta)
• Insulin dependent diabetes
• History of exposure to any recombinant proteins or peptides used for bone formation (i.e., Infuse Bone Graft, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft)
• Hypersensitivity or allergy to any components of the study treatments including, but not limited to, bone morphogenetic proteins (BMPs); tricalcium phosphate (TCP); PLGA polymer
• History of any allergy resulting in anaphylaxis
• Treatment with an investigational therapy (drug, device, and/or biologic) within 120 days (or 5 half-lives, whichever is greater) prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment; prior or planned use of rhBMP-2
• Pregnant at final Screening evaluation prior to Day 1 pre-procedure or interested in trying to conceive a child (both females and males) in the next 12 months or nursing
• Any condition that would interfere with the subject's ability to comply with study instructions or prohibit Radiographic assessments that might confound the interpretation of the study or put the subject at risk
• Patients taking any drug known to interfere with bone/soft tissue healing. See "Medication protocol" section of the protocol.
• Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.