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The primary objective of this study is to evaluate the implant stability at the time of abutment placement on implants placed in healed extraction sockets treated with Straumann BoneCeramic (SBC) versus Freeze Dried Bone Allograft (FDBA).
Subjects will undergo a single tooth extraction and then will be randomized to receive SBC or FDBA. Following a healing period of 6 months, a core biopsy will be taken of the augmented site and a dental implant will be placed. The subject will be followed for one year following dental implant placement for implant success and survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Straumann BoneCeramic | Active Comparator | In the test group, the subjects will receive the Bone Graft Material Straumann BoneCeramic in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction. |
|
| Freeze Dried Allograft Bone | Active Comparator | In the control group, the subjects will receive Bone Graft Material Freeze Dried Allograft Bone in combination with a collagen membrane for preservation of the alveolar ridge after tooth extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Graft Material | Device | After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of Straumann Bone Ceramic or Freeze Dried Allograft Bone (FDBA) with a resorbable collagen membrane (Bio-Gide) for preservation of the alveolar ridge following tooth extraction. Following 6 months of healing, a core of bone will be taken from the surgical site and a dental implant will be placed. The subjects will then be followed for 12 months following dental implant placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant stability will be assessed by recording the maximum torque achieved when placing the abutment. The implant will be considered stable if a minimum of 35 Ncm of torque is achieved. | Six weeks following dental implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Histological evaluation | 6 months following tooth extraction | |
| Alveolar ridge width and height changes | 6 months following tooth extraction | |
| Periodontal measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S. Rosen, DMD, MS | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Yardley | Pennsylvania | 19067 | United States |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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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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| 6 months following tooth extraction and 6 and 12 months following implant placement |
| Grafting procedure success rate | 14 days, 1 month, 3 months, and 6 months following tooth extraction |
| Implant success and survival rate | 6 weeks, 12 weeks, 6 months, and 12 months following implant placement |
| Mesial and distal implant bone level changes | 6 weeks, 12 weeks, 6 months, and 12 months following implant placement |
| Patient satisfaction | 6 and 12 months following implant placement |
| D019637 |
| Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |