Alveolar Bone Changes in Diabetes (ABCD) Study (NCT02395315) | Clinical Trial Compass
CompletedNot Applicable
Alveolar Bone Changes in Diabetes (ABCD) Study
United States42 participantsStarted 2015-12
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in alveolar bone vascularity among well-controlled and not well-controlled diabetic patients.