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Trial record 89 of 119 for:    ZIRCONIUM

Alveolar Bone Changes in Diabetes (ABCD) Study (ABCD)

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ClinicalTrials.gov Identifier: NCT02395315
Recruitment Status : Active, not recruiting
First Posted : March 23, 2015
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

Type 2 Diabetes Mellitus (DM) is a very prevalent metabolic disorder in the adult population affecting roughly 17.7 million people in the US alone. The harmful effect of DM on implant integration and survival has been attributed to vascular complications in the alveolar bone that lead to compromised blood supply and decreased bone density. Nonetheless, the specific detrimental effects of DM in the alveolar bone have not been investigated in humans.

People with DM generally lose more teeth than persons without diabetes, but implant placement in not well controlled diabetics is not routinely performed due to the lack of relevant evidence and the risk for implant failure and associated complications. Chemically modified, micro-rough, hydrophilic (SLActive®) titanium implant surfaces have been shown to accelerate osseointegration of dental implants placed in diabetic animals. It has been hypothesized that this enhanced biologic response is due to the biocompatibility and hydrophilicity of the surface that actively attracts blood and is populated by progenitor cells, and growth factors that improve stromal cell differentiation.

Hypotheses:

It is hypothesized that hyperglycemia results in compromised vascularity in the mandible. Thus, hydrophilic TiZr implant surfaces (Roxolid®) that actively attract fluids and possess excellent osteoconductive properties, may enhance peri-implant bone response in diabetic patients to levels comparable to well-controlled diabetics.


Condition or disease Intervention/treatment
Diabetes Mellitus Device: Well-controlled diabetic (WC) Device: Poorly controlled diabetics (PC)

Detailed Description:

A high level of evidence exists to support the placement of implants in type 2 diabetics with glucosylated hemoglobin (HbA1c) levels within the normoglycemic range. Less information is available for the integration of implants placed in diabetics that cannot achieve good glycemic control, who may represent up to 50% of the diabetic patient population. Recent data from the medical literature have unveiled the deleterious effect of uncontrolled diabetes mellitus (DM) on the bone marrow. The microvascular alterations of DM on skeletal bones lead to microangiopathy, reduced blood flow and fatty degeneration in the bone marrow. Nascent theories that are founded upon the observation of increased levels of soluble osteoprotegerin (OPG) levels in uncontrolled DM implicate disruption of RANKL/OPG signaling as a potential pathway for the diabetes- related bone alterations. Nonetheless, no data is currently available on the pathophysiology of the alveolar bone in patients with DM.

It is hypothesized that 1) hyperglycemia results in compromised vascularity in the mandible, thus 2) hydrophilic TiZr implant surfaces (Roxolid®) that actively attract fluids and possess excellent osteoconductive properties, may enhance peri-implant bone response in not well-controlled diabetics (NCD) to levels comparable to well-controlled diabetics (WCD). We further hypothesize that the expected decreased RANKL/OPG ratio in NCD versus WCD will not recover during post-surgery bone remodeling. To assess our hypotheses, we will recruit n=21 type II WCD (HbA1c≤7.0%) and n=21 type II NCD (7.5%<HbA1c≤10%) seeking implant placement in the mandible. We will collect intra-operative bone specimens at baseline and blood samples to assess bone structural alterations (H&E stain), microvascular density (immunohistochemistry), bound RANKL/OPG (immunohistochemistry) and serum RANKL/OPG (ELISA). Implant integration and success will be assessed at 3, 6, 12 and 36-months.

Obtained results will give dental researchers new insights into the pathophysiology of the alveolar bone in diabetes and will provide information on the safety and efficacy of implant placement in type II diabetic patients that cannot control their glycemic status. Collectively, this work will pave the way for identifying efficacious implant treatment modalities for persons that live with type II diabetes to alleviate the morbidity associated with tooth loss in this susceptible population group.


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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Placement of Hydrophilic TiZr Implants to Enhance Implant Survival in Diabetic Patients: A Prospective, Two-arm, Cohort Study
Actual Study Start Date : December 2015
Actual Primary Completion Date : August 2018
Estimated Study Completion Date : December 31, 2020

Group/Cohort Intervention/treatment
Well-controlled diabetic (WC)
well-controlled diabetic controls (HbA1c ≤ 7.0%), individuals will receive a single 4.1 Titanium-Zirconia, hydrophilic (Roxolid) implant placed in the posterior mandible, a bone core will be taken for histologic and histomorphometric analysis.
Device: Well-controlled diabetic (WC)
Each individual will receive one implant (4.1 Titanium-Zirconia, hydrophilic-Roxolid), that will be placed in the posterior mandible.

Poorly controlled diabetics (PC)
Poorly controlled diabetics (HbA1c >7.5% & <10%), individuals will receive a single 4.1 Titanium-Zirconia, hydrophilic (Roxolid) implant placed in the posterior mandible, a bone core will be taken for histologic and histomorphometric analysis.
Device: Poorly controlled diabetics (PC)
Each individual will receive one implant (4.1 Titanium-Zirconia, hydrophilic-Roxolid), that will be placed in the posterior mandible.




Primary Outcome Measures :
  1. Differences in alveolar bone vascularity among well-controlled and not well-controlled diabetic patients. [ Time Frame: Baseline (intra-operative bone sample) ]
    The difference between alveolar bone vascularity of well-controlled and not well-controlled diabetic patients by immunostaining


Secondary Outcome Measures :
  1. RANK-L to OPG ratio [ Time Frame: Baseline to 8 weeks ]
    A comparison between RANK-L to OPG ratio to determine the state of bone remodeling in each cohort.


Other Outcome Measures:
  1. Differences in alveolar bone mineralization [ Time Frame: Baseline (intra-operative bone sample) ]
    Comparison of bone mineralization between the two cohorts via histomorphometric measurement of vital bone percentage at the time of implant surgery

  2. ISQ values as a surrogate for implant stability [ Time Frame: Time of implant surgery-36 months ]
    Recording of the ISQ values (Osstel) and maximum insertion torque during implant placement as surrogates for primary implant stability.

  3. Implant survival and success assessment at 3-months, 6-months, 1-year and 3-years post-loading [ Time Frame: 3 years ]
    Implant survival and success assessment at 3-months, 6-months, 1-year and 3-years post-loading

  4. Marginal bone level assessment [ Time Frame: 3 years ]
    Assessment of marginal bone level maintenance around the implants at 3-months, 6-months, 1-year and 3-years post-loading. Periapical radiographs will be obtained using a paralleling technique with customized film holders will be obtained at baseline

  5. Implant surgery-related complications [ Time Frame: 3 months ]
    Short-term soft tissue and implant-related complications associated with implant surgery recorded at every post-op visit up to 3-months post-surgery



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with diagnosed type II DM exhibiting at least one edentulous site in the posterior mandible or canine region presenting with levels of HbA1c >7.5% & <10% for enrollment in the PC group and HbA1c ≤ 7.0% for enrollment in the WC group.
Criteria

Inclusion Criteria:

Adult patients aged 18-85 years with diagnosed DM2.

History of DM2 for at least two years prior to enrollment.

At least one edentulous site in the canine or posterior mandible regions.

HbA1c >7.5% & <10% for enrollment in the test group.

HbA1c ≤ 7.0% for enrollment in the control group.

Available for follow up at 12 months.

Exclusion Criteria:

Mandibular incisor sites that will not allow bone core retrieval due to limited alveolar bone width (ridge width <5mm, height <10mm) as confirmed by pre-operative CBCT.

Smokers: current, or ex-smokers with <2 years cessation.

Active periodontal disease.

Medications that affect bone healing (e.g. bisphosphonates or chronic steroids).

Patients who are carriers of transmissible disease(s) that may unnecessarily expose laboratory personnel to risks.

Participants with a physician-diagnosed osteoporosis (Z-score ≤ -2).

Females during pregnancy or lactation and females that plan to become pregnant in the following year.

Patients that will not agree to participate in this study or sign the consent form.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395315


Locations
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United States, Minnesota
University of Minnesota Advanced Education in Periodontology
Minneapolis, Minnesota, United States, 55455
United States, Texas
University of Texas
Houston, Texas, United States, 78229-39000
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7444
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Washington
Investigators
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Principal Investigator: George Kotsakis, DDS University of Washington

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02395315     History of Changes
Other Study ID Numbers: Tamirshalev
First Posted: March 23, 2015    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Diabetes Mellitus
Osseointegration
Bone vascularity
Primary implant stability
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases