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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
CopiOs Pericardium, Puros Cancellous
University of Colorado Denver School of Dental Medicine
Aurora, Colorado, United States
Indiana University
Indianapolis, Indiana, United States
University of Texas Health Sciences Center at Houston
Houston, Texas, United States
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, United States
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.
Time frame: 6 months
Mean Wound Healing Index at 6 Months
Score Description 1. Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort or flap dehiscence 2. Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence but no suppuration 3. Poor wound healing with significant gingival edema, erythema, patient discomfort or flap dehiscence with suppuration
Time frame: 6 months
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