Alveolar Bone Changes in Diabetes (ABCD) Study

Completed

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02395315

Run by

University of Minnesota

People needed

42

Starts

2015-12-01

Expected to finish

2021-11-07

Last updated by the study team

2022-03-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Minnesota Advanced Education in Periodontology — Minneapolis, Minnesota, United States
• University of Texas — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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