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| Name | Class |
|---|---|
| Zimmer Dental | INDUSTRY |
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This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.
The study will evaluate the use of CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft, with the use of Puros Cancellous Particulate Allograft (Puros Cancellous), a mineralized allograft, for the augmentation of localized alveolar ridge defects in edentulous sites. The purpose of the study will be to determine placement time, ease of use, stability, esthetics and to clinically evaluate the efficacy of the list products. A biopsy will be taken from a subset of the patient population, at one investigational site, to evaluate the grafted site's formation of new bone. The study hypothesis is that if CopiOs Pericardium and Puros Cancellous are used, the a single, localized alveolar ridge defect will clinically improve at an edentulous site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CopiOs Pericardium Membrane | Experimental | Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CopiOs Pericardium Membrane | Device | CopiOs Pericardium, Puros Cancellous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Horizontal Ridge Widths From Baseline to 6 Months | The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Wound Healing Index at 6 Months | Score Description
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Mealy | University of Texas Health Sciences Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver School of Dental Medicine | Aurora | Colorado | 80045 | United States | ||
| Indiana University |
All enrolled participants took part in the study.
Recruitment was from June 2009 to February 2011. Subjects were recruited from patients attenting the PI's clinic and had one edentulous site which required lateral ridge augmentation prior to dental implant placement.
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| ID | Title | Description |
|---|---|---|
| FG000 | CopiOs Pericardium | Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers. CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CopiOs Pericardium | Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers. CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um). |
| 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 Horizontal Ridge Widths From Baseline to 6 Months | The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient. | Posted | Mean | Standard Deviation | mm | 6 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 | CopiOs Pericardium | Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers. CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft not integrated, pain at surgical site | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Hai Bo Wen, Director of Research | Zimmer Dental | 760-929-4312 | haibo.wen@zimmer.com |
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| 6 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University of Texas Health Sciences Center at Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Sciences Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Mean Wound Healing Index at 6 Months | Score Description
| Posted | Mean | Standard Deviation | units on a scale | 6 months |
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| 0 |
| 51 |
| 14 |
| 51 |
| Surgical Complications | Surgical and medical procedures | Non-systematic Assessment |
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| Infection at surgical site | Infections and infestations | Non-systematic Assessment |
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