Morris H F, Ochi S, Spray J R, Olson J W
Dental Implant Clinical Research Group, VA Medical Center, Ann Arbor, MI, USA.
Ann Periodontol. 2000 Dec;5(1):56-67. doi: 10.1902/annals.2000.5.1.56.
While the use of hydroxyapatite (HA)-coated endosseous dental implants has gained in popularity over the past 10 years, the short-term and long-term predictability and indications for their use remain highly controversial. Some reports suggest that the HA coating may separate from the substructure, undergo dissolution in tissue fluids, and/or contribute to rapid osseous breakdown around the implant. Other reports, however, relate favorable responses to HA-coated implants, which include rapid bone adaptation to the HA, greater stability at uncovering, and increased coronal bone growth. These contradictions may be related to differences in chemical composition of the HA on the implant surface. Most clinicians and researchers may agree that long-term, independent, scientific clinical studies are needed to compare HA-coated and non-HA-coated (titanium-alloy and CP-titanium) implants under the same conditions. Concerns appear in the literature that HA-coated implants experience greater breakdown because they are more susceptible to bacterial colonization due to their roughness and hydrophilicity. Some studies suggest that specific putative periodontal pathogens may adhere to the HA, thereby predisposing the implant to greater peri-implantitis than that experienced by non-HA implants.
A total of 32 clinical research centers, located in various geographic regions of the United States, were selected to participate in a comprehensive clinical study. More than 2,900 HA-coated and non-HA implants were randomized as to location within one of three jaw regions--maxillary anterior, mandibular anterior, and mandibular posterior--and followed for 36 months. It can be assumed that in each of these jaw regions, the conditions associated with both implant surface types would be similar enough to permit meaningful comparisons of periodontal-type measurements that have not previously been reported. Periodontal-type measurements (gingiva, plaque, suppuration, and calculus indices; probing depth; attachment levels; recession; and keratinized tissue width) for each aspect of each implant (mesial, facial, distal, and lingual) were recorded at 3, 6, 9, 12, 18, 24, and 36 months following implant uncovering. The implant was considered the experimental unit for analysis using generalized estimating equation and repeated measure methods. Data for the four aspects of each implant, as well as measurements over time, were all clustered in the unit of analysis.
The percentages of implants with zeros recorded for the indices was remarkably similar for both HA-coated and non-HA implants. While statistically significant differences were found for some of the measurements associated with HA-coated and non-HA implants under certain conditions, these differences were too small to be considered clinically significant.
Overall, there was no clinically significant difference between the periodontal-type measurements for HA-coated and non-HA-coated implants followed for a period from 3 through 36 months. The concerns about HA-coated implants being associated with adverse periodontal responses for the HA chemical composition included in this study appear to be unfounded for a period of clinical performance up to 36 months.
在过去10年中,羟基磷灰石(HA)涂层的骨内牙种植体的使用越来越普遍,但其短期和长期的可预测性以及使用指征仍存在很大争议。一些报告表明,HA涂层可能会与下部结构分离,在组织液中溶解,和/或导致种植体周围骨质快速吸收。然而,其他报告则显示HA涂层种植体有良好的反应,包括骨组织对HA的快速适应、暴露时更高的稳定性以及冠部骨生长增加。这些矛盾可能与种植体表面HA化学成分的差异有关。大多数临床医生和研究人员可能都认同,需要长期、独立、科学的临床研究,以便在相同条件下比较HA涂层和非HA涂层(钛合金和纯钛)种植体。文献中出现了一些担忧,即HA涂层种植体更容易发生损坏,因为其粗糙度和亲水性使其更易受到细菌定植。一些研究表明,特定的假定牙周病原体可能会附着在HA上,从而使种植体比非HA种植体更容易发生种植体周围炎。
总共选择了位于美国不同地理区域的32个临床研究中心参与一项全面的临床研究。2900多个HA涂层和非HA种植体被随机分配到三个颌骨区域之一(上颌前部、下颌前部和下颌后部),并随访36个月。可以假定,在这些颌骨区域中的每一个区域,与两种种植体表面类型相关的条件足够相似,以便对以前未报告过的牙周类型测量进行有意义的比较。在种植体暴露后的3、6、9、12、18、24和36个月,记录每个种植体每个面(近中、颊侧、远中、舌侧)各方面的牙周类型测量值(牙龈、菌斑、化脓和牙石指数;探诊深度;附着水平;退缩;角化组织宽度)。使用广义估计方程和重复测量方法,将种植体视为分析的实验单位。每个种植体四个面的数据以及随时间的测量值,都在分析单位中进行聚类。
HA涂层和非HA涂层种植体指数记录为零的种植体百分比非常相似。虽然在某些条件下,HA涂层和非HA涂层种植体的一些测量值存在统计学上的显著差异,但这些差异太小,不具有临床意义。
总体而言,在3至36个月的随访期内,HA涂层和非HA涂层种植体的牙周类型测量值没有临床显著差异。对于本研究中包含的HA化学成分,担心HA涂层种植体与不良牙周反应相关,在长达36个月的临床观察期内似乎没有依据。