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

April 26, 2009
August 6, 2014
June 2009
December 2011   (final data collection date for primary outcome measure)
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.
Change in Horizontal Ridge widths. Paired sample t-test will be done both overall and by site. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00889265 on ClinicalTrials.gov Archive Site
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
Wound Healing Index [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alveolar Ridge Defect
Device: CopiOs Pericardium Membrane
CopiOs Pericardium, Puros Cancellous
Other Names:
  • Pericardium Membrane
  • Bovine Xenograft
  • Cancellous Particulate
  • Human Allograft
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.
Intervention: Device: CopiOs Pericardium Membrane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
December 2011
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889265
07-801
No
Zimmer, Inc.
Zimmer, Inc.
Zimmer Dental
Principal Investigator: Brian Mealy University of Texas Health Sciences Center at San Antonio
Zimmer, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP