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

NCT01714024 | Completed Results DMC

• 1 other identifier: ZMU 11-2539
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare the healing differences of two metals (trabecular vs. standard titanium) that are used for dental implants. In addition; investigators will be examine these differences in the gene expression profiles in subjects with three conditions associated with delayed healing: diabetes and osteoporosis. The study will last at least 11 weeks consisting of 6 appointments. All visits will be carried out at the GO Health Center within the UNC School of Dentistry. Visits will last between 30 minutes to 3 hours depending on the particular visit. The visits will consist of: Obtaining consent, doing a health history, measuring vital signs, doing dental exams of the teeth and gums, collecting samples of saliva dental radiographs (X-rays), a teeth cleaning, having 4 temporary mini test cylinders placed in areas of the lower jaw where teeth are missing and implant surgery to place up to four permanent implants.

Conditions

Tooth Replacement

Keywords

Dental; Implant; UNC Dental School; Trabecular Metal; Titanium; Healthy Volunteers; Diabetic; Osteopenic; Bone Inductive Properties; Osseous Healing; GO Health; Offenbacher; Zimmer Dental, Inc.

Outcome Measures

Primary Outcomes (1)

• Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.

  Samples were analyzed comparing the osteogenic potential associated with titanium and porous tantalum dental implants (cylinders) at 2 and 4 weeks using transcriptome analyses. The primary outcome data are displayed showing the Average Delta ∆ (Ct) for osteogenic genes relative to the housekeeping markers. The numerical value of the CT is inversely related to the amount of amplicon in the reaction (i.e., the lower the CT, the greater the amount of amplicon).

  2 weeks & 4 weeks post placement

Secondary Outcomes (1)

• Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.

  4 weeks

Study Arms (3)

Healthy Volunteers

EXPERIMENTAL

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

Device: Zimmer Trabecular Metal Test Cylinder; Device: Zimmer Titanium Test Cylinder

Diabetic Subjects

EXPERIMENTAL

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.

Device: Zimmer Trabecular Metal Test Cylinder; Device: Zimmer Titanium Test Cylinder

Osteopenic Subjects

EXPERIMENTAL

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

Device: Zimmer Trabecular Metal Test Cylinder; Device: Zimmer Titanium Test Cylinder

Interventions

Zimmer Trabecular Metal Test Cylinder DEVICE

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; Healthy Volunteers; Osteopenic Subjects

Zimmer Titanium Test Cylinder DEVICE

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; Healthy Volunteers; Osteopenic Subjects

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be adult males or females age 21 to 80 years (inclusive).
• Subjects must be able and willing to follow study procedures and instructions in English.
• Subjects must have read, understood and signed an informed consent form in English.
• Subjects must have at least four mandibular implants as their future treatment needs.
• Subjects must meet one of the following categories to be considered for enrollment:
• Group 1 (control): Subjects must be non-diabetic, no history of smoking within the last two years and no metabolic bone disease diagnosis.
• Group 2 (diabetic): 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. An HbA1C test performed either within past 3 months must be available or one will be done at the first visit by study personnel. Subjects must have no history of smoking within the last two years nor have any diagnosis of metabolic bone disease.
• Group 3 (Osteoporosis or osteopenia): Subjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates. Subjects must have never had intravenous (IV) bisphosphonates. Subjects in this group must be non-diabetic and no history of smoking within the last 2 years.
• Subjects undergoing test cylinder placement should be in adequate periodontal health prior to implant placement. This includes having probing depth ≤ 4 mm for all remaining teeth at the same quadrant of the proposed cylinder placement. Patients with periodontal probing sites with probing depths of up to 5 mm may also be included if bleeding on probing in these sites is absent. Each subject should be considered to be periodontally stable prior to receiving test cylinders.

You may not qualify if:

• Individuals who have a chronic disease with oral manifestations.
• Individuals who exhibit gross oral pathology.
• The use of either antibiotics or chronic use of NSAIDs within 1 month prior to screening examination.
• Individuals that require antibiotic prophylaxis prior to dental treatment.
• Chronic treatment (i.e. two weeks or more) with any medication known to affect periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, Coumadin) within 1 month prior to screening examination.
• Systemic conditions, except diabetes, osteoporosis and osteopenia that are known to affect periodontal status.
• Individual with uncontrolled parafunctional habits, such as clenching and bruxing on objects, that could adversely impact implant survival
• Individuals with a history of intravenous bisphosphonates Individuals with active infectious diseases such as hepatitis, HIV or tuberculosis.
• Individuals with a current tobacco use history.
• Individuals who are known to be pregnant, breastfeeding or planning to become pregnant within 3 months.
• Individuals with blood disorders and /or currently taking anticoagulants medications, unless he or she can provide a current International normalized ratio (INR) showing normal (0.8 - 2.0) values.
• Individuals receiving any therapy known to affect healing, such as high dose corticosteroids, radiation therapy or chemotherapy.
• Individuals allergic to topical or local anesthesia

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Zimmer Dental: collaborator

Study Sites (1)

General & Oral Health Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• This website is affiliated with the UNC School of Dentistry and is primarily used to inform potential participants about research being done within the General and Oral Health Center.

Results Point of Contact

• Title: Steven Offenbacher, DDS, PhD, MMSc
• Organization: UNC School of Dentistry

steven_offenbacher@unc.edu

919-537-3205

Study Officials

• Steven Offenbacher, DDS, PhD, MMSc

  University of North Carolina School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 25, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2016-01

Locations

US (1)