Tooth ReplacementZMUNCT01714024
Dental Implant Study Comparing Two Types of Metals Used for Dental Implants
A study testing Zimmer Trabecular Metal Test Cylinder and Zimmer Titanium Test Cylinder in people with Tooth Replacement, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Replacement
- What is being tested?
- Zimmer Trabecular Metal Test Cylinder and Zimmer Titanium Test Cylinder
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
General & Oral Health Center
Chapel Hill, North Carolina, 27599
About this study
Official title: A Molecular and Cellular Comparison of Bone Inductive Properties Of Trabecular Metal® Vs. Titanium Among Healthy, Diabetic, and Osteopenic Subjects
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.
Read the detailed description
The plan is to recruit subjects into 3 groups: 1) systemically healthy, 2) subjects with diabetes (ADA classification determined by glycosylated hemoglobin A1C levels), and 3) subjects with osteoporosis (limited to those on either no drugs or oral bisphosphonates only). All subjects recruited will have already been approved and treatment planned for implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have mandibular radiographs that show edentulous ridge areas that provide enough alveolar ridge space to place two test cylinders (each approximately 2.9-3 x 5mm) on each side of the mandible. One side will have two titanium test cylinders and the contralateral side will have two trabecular metal test cylinders. After placement of these 4 test cylinders, one will be removed contra laterally from each side at weeks 2 and 4 of healing. Thus, by 28 days all test cylinders will be removed.
It has been our experience that each cylinder after removal will contain enough cells to provide approximately 10-20μg of total RNA. This quantity of total RNA is sufficient to run an Affymetrix chip and have enough mRNA for PCR confirmation. Sampling at 3 days after placement is too soon, as it does not provide adequate mRNA for the analysis, since the clot has not become remodeled or adequately organized to be cellular. Thus, by 1 week organization of the osseous healing will have begun and at week 2 it will be beginning to mature. The week 2 sampling time point) will provide us with early molecular kinetics of the healing response to compare the two metal surfaces and the differences in gene expression that may be associated with diabetes and osteoporosis. At weeks 2 and 4 the test cylinders will be removed using a 5.0 mm diameter tissue punch and a 5 mm trephine drill. Investigators will select 18 random patients (6 subjects per group) to provide (two test cylinders for each, 36 samples) for histology. Investigators will use the trephine drill to remove the 4 week test cylinders in all 3 groups of subjects. In all cases, a subject is eligible for this study by being pretreatment planned to receive a permanent implant bilaterally, which will be placed at donor sites. According to the participant's individual treatment plan, after test cylinders are removed, each site will receive an implant using either a standard 4.1 or 4.7 mm tapered screw vent design implant. The removed test cylinders will be briefly rinsed in saline and prepared chair side for either mRNA extraction or for histology.
- Conditions
- Tooth Replacement
- Being tested
- Zimmer Trabecular Metal Test Cylinder, Zimmer Titanium Test Cylinder
- Keywords
- Dental, Implant, UNC Dental School, Trabecular Metal, Titanium, Healthy Volunteers, Diabetic, Osteopenic, Bone Inductive Properties, Osseous Healing, GO Health, Offenbacher, Zimmer Dental, Inc.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Trabecular Metal Test CylinderDevice
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 CylinderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Subjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis. Receives: 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. Receives: 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 Receives: Device: Zimmer Trabecular Metal Test Cylinder; Device: Zimmer Titanium Test Cylinder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Findings from expression arrays will be used to perform quantitative PCR analyses using SAB Superarrays (SuperArray GEArray), to enable a quantitativeassay of mRNA levels of specific inflammatory and growth factor molecules
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth ReplacementStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Dental
- Responsible party
- Sponsor
- Investigators
- Steven Offenbacher, DDS, PhD, MMSc, Principal investigator, University of North Carolina School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714024
- Sponsor's protocol ID
- ZMU 11-2539
- Acronym
- ZMU
- Status last verified
- Jan 2016
- First submitted
- 17 Oct 2012
- Last updated
- 12 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular and Cellular Comparison of Bone Inductive Properties Of Trabecular Metal® Vs. Titanium Among Healthy, Diabetic, and Osteopenic Subjects
- ClinicalTrials.gov ID
- NCT01714024
- Acronym / sponsor ID
- ZMU / ZMU 11-2539
- Conditions
- Tooth Replacement
- Keywords
- Dental, Implant, UNC Dental School, Trabecular Metal, Titanium, Healthy Volunteers, Diabetic, Osteopenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Zimmer Dental
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Posted 12 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The plan is to recruit subjects into 3 groups: 1) systemically healthy, 2) subjects with diabetes (ADA classification determined by glycosylated hemoglobin A1C levels), and 3) subjects with osteoporosis (limited to those on either no drugs or oral bisphosphonates only). All subjects recruited will have already been approved and treatment planned for implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have mandibular radiographs that show edentulous ridge areas that provide enough alveolar ridge space to place two test cylinders (each approximately 2.9-3 x 5mm) on each side of the mandible. One side will have two titanium test cylinders and the contralateral side will have two trabecular metal test cylinders. After placement of these 4 test cylinders, one will be removed contra laterally from each side at weeks 2 and 4 of healing. Thus, by 28 days all test cylinders will be removed.
It has been our experience that each cylinder after removal will contain enough cells to provide approximately 10-20μg of total RNA. This quantity of total RNA is sufficient to run an Affymetrix chip and have enough mRNA for PCR confirmation. Sampling at 3 days after placement is too soon, as it does not provide adequate mRNA for the analysis, since the clot has not become remodeled or adequately organized to be cellular. Thus, by 1 week organization of the osseous healing will have begun and at week 2 it will be beginning to mature. The week 2 sampling time point) will provide us with early molecular kinetics of the healing response to compare the two metal surfaces and the differences in gene expression that may be associated with diabetes and osteoporosis. At weeks 2 and 4 the test cylinders will be removed using a 5.0 mm diameter tissue punch and a 5 mm trephine drill. Investigators will select 18 random patients (6 subjects per group) to provide (two test cylinders for each, 36 samples) for histology. Investigators will use the trephine drill to remove the 4 week test cylinders in all 3 groups of subjects. In all cases, a subject is eligible for this study by being pretreatment planned to receive a permanent implant bilaterally, which will be placed at donor sites. According to the participant's individual treatment plan, after test cylinders are removed, each site will receive an implant using either a standard 4.1 or 4.7 mm tapered screw vent design implant. The removed test cylinders will be briefly rinsed in saline and prepared chair side for either mRNA extraction or for histology.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Zimmer Trabecular Metal Test Cylinder, Device: Zimmer Titanium Test CylinderSubjects who are non-diabetic, with no history of smoking within the past two years and no metabolic bone disease diagnosis. |
| Diabetic Subjects | Experimental | Device: Zimmer Trabecular Metal Test Cylinder, Device: Zimmer Titanium Test CylinderSubjects 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. |
| Osteopenic Subjects | Experimental | Device: Zimmer Trabecular Metal Test Cylinder, Device: Zimmer Titanium Test CylinderSubjects must be diagnosed with osteoporosis or osteopenia and must be currently under the care of a physician and treatment with oral bisphosphonates |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Group 1 (control): Subjects must be non-diabetic, no history of smoking within the last two years and no metabolic bone disease diagnosis.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer Trabecular Metal Test CylinderFor 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. | Device | Diabetic Subjects, Healthy Volunteers, Osteopenic Subjects |
| Zimmer Titanium Test CylinderFor 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. | Device | Diabetic Subjects, Healthy Volunteers, Osteopenic Subjects |
Primary outcome
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.
Time frame: 2 weeks & 4 weeks post placement
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Offenbacher, DDS, PhD, MMSc principal investigator
University of North Carolina School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer Trabecular Metal Test Cylinder and Zimmer Titanium Test Cylinder in people with Tooth Replacement, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium. (time frame: 2 weeks & 4 weeks post placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.