Clinical trial NCT00889265: CopiOs® Pericardium Membrane for Localized Alveolar Ridge Augmentation
Official title: Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft for Localized Alveolar Ridge Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Defect
Keywords: Alveolar Bone Augmentation
Implant Surgery
Guided Bone Regeneration (GBR)
Guided Tissue Regeneration (GTR)
Bone Graft
Periodontal Surgery
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Zimmer Dental
First posted: 2009-04-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Change in Horizontal Ridge Widths From Baseline to 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Mean Wound Healing Index at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver School of Dental Medicine
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Houston
country: United States
facility: University of Texas Health Sciences Center at Houston
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Sciences Center at San Antonio
name: Brian Mealy
role: PRINCIPAL_INVESTIGATOR
References: