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The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.
The patient is identified and surgical site and sides reviewed. The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible.
Local anesthesia is administered and attention directed to the bilateral identified teeth. Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal. The sites are curetted as indicated, irrigated with normal saline irrigation , then the sterile bone graft material (allograft and vegetable ivory bone graft) are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture. Once hemostasis is obtained and pot operative care instructions are given, the patient is monitored for 30 minutes following the procedure then discharged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant 1 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
|
| Participant 2 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
|
| Participant 3 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
|
| Participant 4 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Grafting | Procedure | Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with completely healed bone graft surgical site | The number of participants who have bone volumes that match or exceed the control sites. | Six Months |
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Inclusion Criteria:
Have parallel sites from which teeth have been extracted
Exclusion Criteria:
They are not a candidate for bone grafting or a dental implant
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Stanczyk | Contact | 315-263-7976 | markstanczyk@dentivia.com | |
| Michele O'Brien, HRPP | Contact | +1 315 744 1186 | micheleobrien@sjhsyr.org |
| Name | Affiliation | Role |
|---|---|---|
| Pasquale Scutari, D.D.S. | St Joseph's Hospital, Syracuse | Principal Investigator |
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| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Participant 5 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
|
| Vegetable Derived | Other | Tooth extraction followed by socket preservation with vegetable ivory |
|
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| D019637 |
| Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |