Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations (NCT07078331) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations
Armenia, Israel45 participantsStarted 2025-07-17
Plain-language summary
This study's objective is to evaluate OsteoAdapt DE's safety and performance in comparison to Xenograft particulate bone graft for alveolar ridge augmentation. Additionally, the study aims to optimize OsteoAdapt DE dosing for future studies by assessing two concentrations: a low dose (0.8 mg/cc) and a high dose (2.0 mg/cc).
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 22 or older at the time of signing informed consent
✓. 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
✓. Tooth root in position allowing a bone core sample to be harvested within the former socket
✓. 6mm of alveolar bone height without impinging on the maxillary sinus or inferior alveolar canal
✓. Dehiscence of ≤ 2 mm on the buccal bony wall at the time of extraction
✓. Presence of other socket walls, mesial, distal and lingual walls
✓. 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
✓. 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
✕. 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
What they're measuring
1
Successful placement of a dental implant with primary stability (>25 N cm)
Timeframe: 6 months
2
Rates of serious adverse events related to the grafting material and / or grafting procedure
Timeframe: 6 months
3
Occurrence of any unplanned additional procedures at the implantation site related to the grafting material or grafting procedure
✕. 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)