Alveolar Bone Changes in Diabetes (ABCD) Study



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 85
Updated:12/20/2017
Start Date:December 2015
End Date:August 2018
Contact:Tamir Shalev, DMD
Email:Shale007@umn.edu
Phone:6123231399

Use our guide to learn which trials are right for you!

Placement of Hydrophilic TiZr Implants to Enhance Implant Survival in Diabetic Patients: A Prospective, Two-arm, Cohort Study

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.

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% 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.

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.
We found this trial at
3
sites
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
Phone: 612-323-1399
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials