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
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Alveolar Ridge Defect
Intervention: Device: CopiOs Pericardium Membrane

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was from June 2009 to February 2011. Subjects were recruited from patients attenting the PI's clinic and had one edentulous site which required lateral ridge augmentation prior to dental implant placement.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled participants took part in the study.

Reporting Groups
  Description
CopiOs Pericardium

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.

CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um).


Participant Flow:   Overall Study
    CopiOs Pericardium  
STARTED     51 [1]
COMPLETED     44  
NOT COMPLETED     7  
Adverse Event                 1  
Lost to Follow-up                 5  
Protocol Violation                 1  
[1] Date Enrollment Started: 07/21/2009 Date Enrollment Completed: 02/15/2011 Total enrolled: 51



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CopiOs Pericardium

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.

CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um).


Baseline Measures
    CopiOs Pericardium  
Number of Participants  
[units: participants]
  51  
Age  
[units: years]
Mean ± Standard Deviation
  49  ± 15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     43  
>=65 years     8  
Gender  
[units: participants]
 
Female     38  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     51  



  Outcome Measures
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1.  Primary:   Change in Horizontal Ridge Widths From Baseline to 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Mean Wound Healing Index at 6 Months   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Hai Bo Wen, Director of Research
Organization: Zimmer Dental
phone: 760-929-4312
e-mail: haibo.wen@zimmer.com


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