CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation

Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft 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 Overview

• Status: Completed
• Conditions: Alveolar Ridge Defect
• Intervention / Treatment: Device: CopiOs Pericardium Membrane

Detailed Description

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
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver School of Dental Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Sciences Center at Houston
    • San Antonio, Texas, United States, 78229-3900
      • University of Texas Health Sciences Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, of any ethnicity, between 18 and 99 years of age
• Health status of P1(ASA I) or P2 (ASA II), as classified by the American Academy of Anesthesiologists
• Able to communicate with the investigator and read, understand, and sign the informed consent form
• No evidence of active moderate or severe periodontitis
• Must be available for multiple follow-up visits for the duration of the study
• The study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5 mm in its smallest buccolingual dimension as measured by ridge-mapping calipers (#RIDGE-CALIPER, Salvin Dental Specialties, Inc., Charlotte, NC).

Exclusion Criteria:

• Inability or failure to maintain adequate oral hygiene
• Women who are bread-feeding, pregnant, or who intend to become pregnant during this study period. Women of childbearing potential should be practicing a medically accepted method of birth control
• Patients with unstable systemic diseases
• Patients with compromised immune system (e.g. uncontrolled diabetes, etc.) or unstable bleeding disorder
• Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HEV, etc.)
• Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.)
• Patients taking steroid medications or undergoing other immunosuppressive therapy
• Radiation, cancer therapy, and/or radiation specifically at the oral cavity within the last 6 months
• History of previous ridge augmentation at the site of interest
• Augmentation sites with localized pathology
• Patient who has participated in a clinical trial within 30 days of being enrolled in this study, is currently enrolled in another study, or plans to enroll in another study before the completion of of this study.
• Unresolved oral pathologies (e.g. periodontal disease, caries, etc.)
• Medications or conditions contraindicated for bone regeneration: methotrexate, corticosteroids, history of bisphosphonate use, cyclosporine-A, etc.
• Patients who have more than a minimal tobacco use (e.g. >10 cigarettes per day)
• Other conditions the investigator may feel would inhibit the patient from being a good candidate for this study or which are contraindicated in the Directions for Use.
• Note: Careful consideration should be given to alternative therapies prior to performing bone grafting in patients who have severe endocrine-induced bone diseases (e.g.hyperparathyroidism), or who are undergoing current therapy with drugs that intervene in calcium metabolism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: Pericardium Membrane; Bovine Xenograft; Cancellous Particulate; Human Allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Wound Healing Index at 6 Months	Score Description; 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	6 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Zimmer Dental
• Investigators: Principal Investigator: Brian Mealy, University of Texas Health Sciences Center at San Antonio

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 26, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Bone Graft; Periodontal Surgery; Alveolar Bone Augmentation; Implant Surgery; Guided Bone Regeneration (GBR); Guided Tissue Regeneration (GTR)
• Other Study ID Numbers: 07-801