Diabetes Effects on Long-Term Implant Survival and Success

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DESCRIPTION (provided by applicant): Sub-optimal glycemic control remains a major barrier to dental implant therapy for diabetes patients. With over 25 million individuals affected in the US, understanding the relationship between glycemic control and implant-related outcomes becomes critical to the development of clinical guidelines for the care of these patients. While emerging evidence demonstrates promise for implant osseointegration independent of glycemic levels, there remains no clear evidence of the effects of glycemic control for implant-related complications under long-term function. Purpose: The goal of this study is (Aim 1) to clarify the effects of glycemic control on dental implant survival and related biologic complications under long-term function in patients with type 2 diabetes. It also (Aim 2) examines these associations relative to long-term effects of sub- optimal glycemic control on two different restorative schemes (fixed partial or removable complete). Hypothesis: Long-term risks for biologic complications and implant failure are independent of glycemic control for type 2 diabetes patients. Furthermore, the risks of biologic complications and implant failure are independent of the type of prosthetic restoration patients with sub-optimal glycemic control. Methods: This parallel design, prospective cohort study will assess dental implant survival, biologic complications, and implant stability under long-term function relative to glycemic levels. This application capitalizes on high subject retention rates from previous investigations by extending beyond one year the evaluation period for our existing cohort of 121 implant patients (40 non-diabetic, 81 type 2 diabetes patients with HbA1c between 6-12%), and expands the study population with the enrollment of an additional 42 patients (14 per group: non-diabetic (HbA1c<6.0%), well-controlled (6.0%<HbA1c<8.0%) and poorly-controlled (8.0%<HbA1c<12.0%) diabetic). The resulting long- term evaluation period will extend between 3 to 9 years. Outcomes: Assessments include implant survival, implant-related biologic complications, and resonance frequency analysis as a measure of implant stabilization. Outcomes will be analyzed relative to glycated hemoglobin levels (HbA1c) taken at 6 month intervals over the course of the study. Implications: This investigation addresses critical deficiencies in assessment and reporting of glycemic levels in the literature currently guiding implant therapy in diabetes patients. It builds on emerging evidence of successful osseointegration independent of glycemic levels by examining long-term survival and comp[lications. This investigation challenges existing paradigms that limit implant therapy to patients with good glycemic control. It will contribute to the establishment of evidence-based guidelines for the assessment and application of dental implant therapy for patients with type-2 diabetes. This may extend the benefits of implant therapy to many of these patients that struggle with dietary management of their disease due to masticatory dysfunction.