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| Name | Class |
|---|---|
| Camlog Oral Reconstruction Foundation | OTHER |
| BioHorizons, Inc. | INDUSTRY |
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The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.
The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing two widely accepted treatment modalities that are used to maintain ridge dimension after a tooth extraction.
The specific aims of the study are:
It is currently unclear if one treatment is more effective than the other. The two treatments being compared are:
Treatment 1: Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Treatment 2: Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10)
MinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration.
Striate+ Membrane: A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place.
Secondary intention healing (without complete flap closure): The wound edges are not brought together (i.e. knee scrape).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Graft Alone | Active Comparator | Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) |
|
| Bone Graft + Membrane | Experimental | Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MinerOss® X Plug | Device | A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| radiographic ridge width | To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| gingival thickness | To assess soft tissue changes. | 12 months |
| radiographic alveolar height | To assess radiographic hard tissue changes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Kim, DDS, DMSc | Harvard School of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard School of Dental Medicine | Boston | Massachusetts | 02115 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2023 | Jan 4, 2024 | ICF_000.pdf |
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Randomized Control Clinical Trial
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| Striate+ Membrane | Device | A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place. |
|
| 12 months |
| clinical alveolar height and width | To assess clinical hard tissue changes. | 12 months |