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NCT02395315 · ClinicalTrials.gov registry record

Alveolar Bone Changes in Diabetes (ABCD) Study

A clinical trial, sponsored by University of Minnesota.

Completed
Registry status
42
Enrollment target

NCT02395315: Completed study, sponsored by University of Minnesota.

NCT02395315 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02395315 has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
42 participants
Enrollment target

Study 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.

Primary Outcome

The difference between alveolar bone vascularity of well-controlled and not well-controlled diabetic patients by immunostaining

Interventions

  • DEVICE Well-controlled diabetic (WC)
  • DEVICE Poorly controlled diabetics (PC)

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2015-12
Est. Completion 2021-11-07
University of Minnesota

966 total trials

What the finished NCT02395315 record still lists

NCT02395315 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which Well-controlled diabetic (WC) is the first listed.

NCT02395315 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02395315 about?

NCT02395315 is a clinical study titled "Alveolar Bone Changes in Diabetes (ABCD) 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...

What is the current status of trial NCT02395315?

This trial is currently completed. The enrollment target is 42 participants. The study started on 2015-12. Estimated completion is 2021-11-07.

What interventions are being tested in trial NCT02395315?

The interventions under investigation include: Well-controlled diabetic (WC) (DEVICE), Poorly controlled diabetics (PC) (DEVICE).

Who is sponsoring clinical trial NCT02395315?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02395315, the US trial registry maintained by the National Library of Medicine. NCT02395315 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.