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 range
22 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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)