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Purpose of the single arm study is to clinically and histologically evaluate alloplastic in-situ hardening, moldable beta-tricalcium phosphate(TCP) bone graft material and polylactide membrane in alveolar ridge preservation following extraction of non-molar teeth with non-containable extraction sockets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device treatment | Experimental | easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easy-graft CLASSIC (beta-Tricalcium Phosphate) | Device | easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Radiographic Measurements of Bone Ridge Dimensions | Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements. | Change from Baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Digital Measurements of Soft Tissue Dimensions | Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements. | Change from baseline at 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Dentistry | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Treatment | easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Treatment | easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Radiographic Measurements of Bone Ridge Dimensions | Cone-beam computed tomography (CBCT) was taken at the ridge preservation procedure (baseline) and 3 months after the procedure. The horizontal ridge width was measured at 1, 3, 5 and 7 mm below the alveolar bone crest. Overall change is the average of all measurements. | Posted | Mean | Standard Deviation | mm | Change from Baseline at 3 months |
|
5 months after ridge preservation surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Treatment | easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane easy-graft CLASSIC (beta-Tricalcium Phosphate): easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akane Takemura | Sunstar Americas, Inc. | 8477944276 | akane.takemura@us.sunstar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2017 | Jan 20, 2021 | Prot_SAP_001.pdf |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Units | Counts |
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| Secondary | Change in Digital Measurements of Soft Tissue Dimensions | Pre- and post-surgery casts were made from impressions and scanned with a digital scanner. The soft tissue width was measured at 1, 3 and 5 mm below the ridge crest. Overall change is the average of all measurements. | Posted | Mean | Standard Deviation | mm | Change from baseline at 5 months |
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| 0 |
| 9 |
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| 9 |
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