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Dental Implant Study Comparing Two Types of Metals Used for Dental Implants (ZMU)

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ClinicalTrials.gov Identifier: NCT01714024
Recruitment Status : Completed
First Posted : October 25, 2012
Results First Posted : July 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborator:
Zimmer Dental
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Tooth Replacement
Interventions: Device: Zimmer Trabecular Metal Test Cylinder
Device: Zimmer Titanium Test Cylinder

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy Volunteers

Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.

Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Diabetic Subjects

Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.

Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Osteopenic Subjects

Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates

Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Participant Flow:   Overall Study
    Healthy Volunteers   Diabetic Subjects   Osteopenic Subjects
STARTED   13   18   11 
COMPLETED   12   12   8 
NOT COMPLETED   1   6   3 



  Baseline Characteristics

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
Healthy Volunteers

Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis.

Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Diabetic Subjects

Subjects must have Type 2 diabetes mellitus as diagnosed by a physician or in medication history. The condition must be currently diagnosed and treated by medications and/or insulin.

Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Osteopenic Subjects

Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates

Zimmer Trabecular Metal Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.

Zimmer Titanium Test Cylinder: For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Healthy Volunteers   Diabetic Subjects   Osteopenic Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 12   12   8   32 
Age 
[Units: Participants]
Count of Participants 		       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8  66.7%      5  41.7%      3  37.5%      16  50.0% 
>=65 years      4  33.3%      7  58.3%      5  62.5%      16  50.0% 
Age 
[Units: Years]
Mean (Full Range) 		 59.33 
 (39 to 75)  		 64.33 
 (54 to 71)  		 66.38 
 (59 to 76)  		 64.22 
 (39 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      7  58.3%      5  41.7%      8 100.0%      20  62.5% 
Male      5  41.7%      7  58.3%      0   0.0%      12  37.5% 
Region of Enrollment 
[Units: Participants]
 		       
United States   12   12   12   36 


  Outcome Measures

1.  Primary:   Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.   [ Time Frame: 2 weeks & 4 weeks post placement ]
  Show Outcome Measure 1

2.  Secondary:   Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.   [ Time Frame: 4 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven Offenbacher, DDS, PhD, MMSc
Organization: UNC School of Dentistry
phone: 919-537-3205
e-mail: steven_offenbacher@unc.edu



Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01714024     History of Changes
Other Study ID Numbers: ZMU 11-2539
First Submitted: October 17, 2012
First Posted: October 25, 2012
Results First Submitted: February 17, 2017
Results First Posted: July 12, 2017
Last Update Posted: October 12, 2017