Diabetes Effects on Long-Term Implant Survival and Success

描述(由申请人提供)：次优的血糖控制仍然是糖尿病患者牙种植体治疗的主要障碍。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制定这些患者的临床护理指南至关重要。虽然新出现的证据表明，种植体的骨整合与血糖水平无关，但仍没有明确的证据表明，在长期功能状态下，血糖控制对种植体相关并发症的影响。目的：本研究的目的是(1)明确血糖控制对2型糖尿病患者长期功能状态下种植体存活率和相关生物并发症的影响。它还(目标2)检查了两种不同的恢复方案(固定的、部分的或完全可移除的)的次优血糖控制对长期效果的影响。假设：生物并发症和植入失败的长期风险与2型糖尿病患者的血糖控制无关。此外，生物并发症和植入失败的风险与血糖控制不佳的假体修复患者的类型无关。方法：这项平行设计的前瞻性队列研究将评估长期功能下相对于血糖水平的牙种植体存活率、生物并发症和植体稳定性。这项应用利用了之前研究中的高受试者保留率，将我们现有的121名植入患者(40名非糖尿病患者，81名糖化血红蛋白在6-12%之间的2型糖尿病患者)的评估期延长到一年以上，并扩大了研究人群，增加了42名患者(每组14名：非糖尿病(HbA1c&lt；6.0%)、控制良好(6.0%；HbA1c&lt；8.0%)、糖尿病控制不佳(8.0%&lt；HbA1c&lt；12.0%))。由此产生的长期评价期将从3年到9年不等。结果：评估包括种植体存活率、与种植体相关的生物并发症，以及作为衡量种植体稳定性的共振频率分析。结果将根据糖化血红蛋白水平(HbA1c)在研究过程中每隔6个月采集一次进行分析。影响：这项调查解决了目前指导糖尿病患者植入治疗的文献中在评估和报告血糖水平方面的严重缺陷。它通过检查长期存活和并发症，建立在独立于血糖水平的成功骨整合的新证据的基础上。这项研究挑战了将植入物治疗限制在血糖控制良好的患者的现有范例。它将有助于为2型糖尿病患者评估和应用牙种植体疗法建立循证指南。这可能会将种植治疗的好处扩大到许多由于咀嚼功能障碍而在饮食管理方面苦苦挣扎的患者。

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.