Diabetes Effects on Long-Term Implant Survival and Success

描述（申请人提供）：血糖控制欠佳仍然是糖尿病患者种植牙治疗的主要障碍。在美国有超过2500万人受到影响，了解血糖控制和植入物相关结果之间的关系对于这些患者护理的临床指南的发展至关重要。虽然新出现的证据表明种植体骨整合的前景与血糖水平无关，但在长期功能下，血糖控制对种植体相关并发症的影响仍然没有明确的证据。目的：本研究的目的是（目的1）阐明血糖控制对2型糖尿病患者种植体长期存活及相关生物学并发症的影响。它还（目的2）研究了在两种不同的恢复方案（固定部分或可移动完全）中，与亚最佳血糖控制的长期影响相关的这些关联。假设：2型糖尿病患者生物并发症和植入物失效的长期风险与血糖控制无关。此外，生物并发症和假体失败的风险与血糖控制不佳的患者的假体修复类型无关。方法：这项平行设计的前瞻性队列研究将评估种植体存活、生物并发症和种植体在长期功能下相对于血糖水平的稳定性。本研究将121例植入患者（40例非糖尿病患者，81例HbA1c在6-12%之间的2型糖尿病患者）的评估期延长了一年以上，利用了以往研究的高受试者保留率，并扩大了研究人群，增加了42例患者（每组14例：非糖尿病（HbA1c<6.0%）、控制良好（6.0%<HbA1c<8.0%）和控制不良（8.0%<HbA1c<12.0%）糖尿病患者）。由此产生的长期评估期将延长3至9年。结果：评估包括种植体存活，种植体相关的生物并发症，共振频率分析作为种植体稳定的衡量标准。结果将与研究过程中每隔6个月测量一次的糖化血红蛋白水平（HbA1c）进行分析。意义：本研究解决了目前指导糖尿病患者植入治疗的文献中评估和报告血糖水平的关键缺陷。该研究是建立在独立于血糖水平的成功骨整合的新证据的基础上，通过检查长期生存和并发症。这项研究挑战了现有的范式，即限制植入治疗的患者血糖控制良好。这将有助于为2型糖尿病患者种植牙治疗的评估和应用建立循证指南。这可能会将种植疗法的益处扩展到许多由于咀嚼功能障碍而与饮食管理作斗争的患者。

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.