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

Launched by THERADAPTIVE, INC · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called OsteoAdapt DE to help rebuild the bone in the jaw after a tooth has been removed. When you lose a tooth, the bone where the tooth used to be can shrink, which can make it harder to place a dental implant later on. This study is checking how safe and effective OsteoAdapt DE is compared to a commonly used bone graft material called Xenograft. The researchers are also testing two different doses of OsteoAdapt DE to find the best amount to use in future studies.

People who might join this study are adults needing to have a single tooth removed and who plan to get a dental implant in that spot. To be eligible, the tooth’s root must be in a position that allows the doctor to take a small bone sample during the procedure, and there needs to be enough bone around the tooth without involving certain nearby areas like the sinus or nerve canal. Participants should be able to attend follow-up visits and agree to use contraception if applicable. The study is currently recruiting and will involve regular check-ups to see how well the bone heals with the new treatment. If you are interested, it’s important to know that certain health conditions or medications, like active infections, smoking, or some bone diseases, could exclude someone from joining. This study aims to improve options for people who need bone rebuilding after tooth extraction to support future dental implants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 22 or older at the time of signing informed consent
• • 2. Subject requires extraction of a single tooth due to extensive carious lesions, prosthetic or endodontic failure, root fracture, or other reasons with dental implant treatment planned at the site
• • 3. Tooth root in position allowing a bone core sample to be harvested within the former socket
• • 4. 6mm of alveolar bone height without impinging on the maxillary sinus or inferior alveolar canal
• • 5. Dehiscence of ≤ 2 mm on the buccal bony wall at the time of extraction
• • 6. Presence of other socket walls, mesial, distal and lingual walls
• • 7. The subject is willing and able to be present for routine follow up visits, comply with postoperative management program, and is able to understand and sign the informed consent form
• • 8. Willing to use a reliable method of contraception (for woman of childbearing potential and males with a partner who is of childbearing potential)
• Exclusion Criteria:
• • 1. Active localized or systemic infection
• • 2. Untreated periodontal disease
• • 3. Presence of a fenestration larger than 3 mm in diameter in the buccal wall at the time of extraction
• • 4. Inadequate bone dimensions or restorative space to place a dental implant
• • 5. The subject uses, or has used within 30 45 days of surgery, tobacco or nicotine or is prescribed steroids such as cortisone
• • 6. 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
• • 7. 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)
• • 8. Insulin dependent diabetes
• • 9. 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)
• • 10. Hypersensitivity or allergy to any components of the study treatments including, but not limited to, bone morphogenetic proteins (BMPs); tricalcium phosphate (TCP); PLGA polymer
• • 11. History of any allergy resulting in anaphylaxis
• • 12. 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
• • 13. 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
• • 14. 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
• • 15. Patients taking any drug known to interfere with bone/soft tissue healing. See "Medication protocol" section of the protocol.
• • 16. 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.