CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft for Localized Alveolar Ridge Augmentation|
- Change in Horizontal Ridge Widths From Baseline to 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- Mean Wound Healing Index at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence
- Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration
- Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration
|Study Start Date:||June 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: CopiOs Pericardium Membrane
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.
Device: CopiOs Pericardium Membrane
CopiOs Pericardium, Puros Cancellous
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889265
|United States, Colorado|
|University of Colorado Denver School of Dental Medicine|
|Aurora, Colorado, United States, 80045|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Texas|
|University of Texas Health Sciences Center at Houston|
|Houston, Texas, United States, 77030|
|University of Texas Health Sciences Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Brian Mealy||University of Texas Health Sciences Center at San Antonio|