Dental Implant Study Comparing Two Types of Metals Used for Dental Implants - Study Results

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

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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.
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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 ]

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2. Secondary:

To Examine the Differences in the Gene Expression Profiles Not Only Comparing Trabecular Metal to Titanium, But Also Examining These Differences in Subjects With Three Systemic Conditions Associated With Delayed Healing: Diabetes and Osteoporosis. [ Time Frame: 2 years ]

Results not yet reported. Anticipated Reporting Date: 08/2017

Serious Adverse Events

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Other Adverse Events

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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: 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
Study First Received:	October 17, 2012
Results First Received:	February 17, 2017
Last Updated:	June 12, 2017

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