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| Name | Class |
|---|---|
| Zimmer Dental | INDUSTRY |
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The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Puros Dermis | Experimental | Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. |
|
| Group 2: Alloderm | Active Comparator | Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puros® Dermis versus Alloderm® | Device | Puros Dermis and Alloderm (both Allograft Tissue Matrix) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non -Inferiority of Dermis to Alloderm | Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of Michigan |
Randomized
Recruitment period was from 08 25 2009 to 04 24 2011. Subjects had a single non-adjacent Miller's class I or II gingival recession defect, greater than or equal to 2mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Subjects for this study were recruited from the PI's clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Puros Dermis | Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis. |
| FG001 | Arm 2: Alloderm | Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Puros Dermis | Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Non -Inferiority of Dermis to Alloderm | Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm. | Posted | Mean | Standard Deviation | mm | 12 months |
|
12 months
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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 | Arm 1: Puros Dermis | Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection, Other | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hai Bo Wen | Zimmer Dental | 760 929 4312 | haibo.wen@zimmer.com |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Ann Arbor |
| Michigan |
| 48109-1078 |
| United States |
| University of Medicine and Dentistry of New Jersey | Newark | New Jersey | 07103-0009 | United States |
| University of Rochester | Rochester | New York | 14620 | United States |
| BG001 |
| Group 2: Alloderm |
Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar. Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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|
| 0 |
| 38 |
| 2 |
| 38 |
| EG001 | Arm 2: Alloderm | Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm. | 0 | 42 | 0 | 42 |
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| D055093 |
| Periodontal Atrophy |