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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).
Prospective, Multi Center, Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Performance, and Dose, of OsteoAdapt DE in Localized Alveolar Ridge Augmentations for Defects Associated with Extraction Sockets - Feasibility Study.
Patients requiring a single tooth extraction (with the intent of placing a dental implant into the regenerated bone in the extraction socket) who signed the consent form and are found eligible for the study (meet the inclusion criteria and none of the exclusion criteria) will be randomized into one of 3 study Arms at a 1:1:1 ratio prior to the extraction procedure:
Study Arm 1 - Investigational (~15 subjects): OsteoAdapt DE with 0.8mg AMP-2 per cc of ReBOSSIS-J packed inside of the extraction socket.
Study Arm 2 - Investigational (~15 subjects): OsteoAdapt DE with 2.0mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket.
Study Arm 3 - Control (~15 subjects): Xenograft particulate bone graft packed inside of the extraction socket (SOC).
The Subjects will be blinded to their arm allocation whereas the treating physician will be unblinded (Single blinded study). Grafting of the prepared socket will be performed at the time of tooth extraction, and all extraction sockets will be covered with a resorbable collagen membrane (e.g. BioGide from Geistlich) prior to reapproximation of buccal and lingual flaps. Primary closure of the extraction socket is not required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose OsteoAdapt DE | Experimental | OsteoAdapt DE with 0.8 mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket |
|
| High Dose OsteoAdapt DE | Experimental | OsteoAdapt DE with 2.0 mg AMP2 per cc of ReBOSSIS-J packed inside of the extraction socket |
|
| Control (Xenograft) | Active Comparator | Xenograft particulate bone graft packed inside of the extraction socket (SOC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsteoAdapt DE (0.8 mg) | Device | Procedure of single tooth extraction and grafting along with related data collection: Implanted OsteoAdapt DE bone graft (0.8 mg) by a trained and qualified study investigator per the IFU, IB and CIP guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Successful placement of a dental implant with primary stability (>25 N cm) | 6 months | |
| Rates of serious adverse events related to the grafting material and / or grafting procedure | 6 months | |
| Occurrence of any unplanned additional procedures at the implantation site related to the grafting material or grafting procedure | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armenia Medical Center | Yerevan | 0078 | Armenia | |||
| Medline Clinic |
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The Subjects will be blinded to their arm allocation whereas the treating physician will be unblinded (Single blinded study)
| OsteoAdapt DE (2.0 mg) | Device | Procedure of single tooth extraction and grafting along with related data collection: Implanted OsteoAdapt DE bone graft (2.0 mg) by a trained and qualified study investigator per the IFU, IB and CIP guidelines |
|
| Xenograft Bone Graft | Device | Procedure of single tooth extraction and grafting along with related data collection: Implanted xenograft bone graft by a trained and qualified study investigator per the IFU, IB and CIP guidelines |
|
| Yerevan |
| 0078 |
| Armenia |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Assuta Medical Center | Tel Aviv | 6971028 | Israel |
| Sheba Medical Center | Tel Litwinsky | 5265601 | Israel |