CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation

This study has been completed.
Sponsor:
Collaborator:
Zimmer Dental
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT00889265
First received: April 26, 2009
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Alveolar Ridge Defect
Device: CopiOs Pericardium Membrane

Study Type: Interventional
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

Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Mean Wound Healing Index at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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


Enrollment: 51
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889265

Locations
United States, Colorado
University of Colorado Denver School of Dental Medicine
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University
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
Sponsors and Collaborators
Zimmer, Inc.
Zimmer Dental
Investigators
Principal Investigator: Brian Mealy University of Texas Health Sciences Center at San Antonio
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT00889265     History of Changes
Other Study ID Numbers: 07-801
Study First Received: April 26, 2009
Results First Received: May 5, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Zimmer, Inc.:
Alveolar Bone Augmentation
Implant Surgery
Guided Bone Regeneration (GBR)
Guided Tissue Regeneration (GTR)
Bone Graft
Periodontal Surgery

ClinicalTrials.gov processed this record on October 23, 2014