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Finite Element Analysis: Connector Designs and Pontic Stress Distribution of Fixed Partial Denture Implant-Supported Metal Framework. 有限元分析:固定局部义齿种植体支撑金属框架的连接体设计和基牙应力分布。
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023048378
Saja Ali Muhsin, Enas Kareem Mohammed, Khalid Bander

This virtual study was designed to evaluate the stress-deformation of a metal fixed partial dentures (FPDs) pontic under different loads using two different connectors. The STL file was generated for a RPD of two implant-supported restorations. The Co-Cr metal substructure was designed with two types of connector design. The pontic is connected to implant-supported crowns with square and round shape connectors. This study was designed for a cementless-retained implant-supported FPD. Finite element modeling (FEM) is used to assess the stress and deformation of the pontic within a metal substructure as the FEM might provide virtual values that could have laboratory and clinical relevance. The Co-Cr alloy mechanical properties like the Poisson ratio and modulus of elasticity were based on the parameters of the three-dimensional structure additive method. Nonparametric analyses (Mann-Whitney U test) was used. The use of square or round connectors often resulted in non-significant changes in stress, and deformation under either three or each loaded point on the occlusal surface of a pontic (P > 0.05). However, the deformation revealed distinct variations between loads of the three points compared to each loaded point (P ≤ 0.05). According to this study data, the pontic occlusal surface appears to be the same in stress and deformation under different loads depending on whether square or round connectors are used. While at the same connector designs, the pontic occlusal surface deformed significantly at three loaded points than it did at each point.

这项虚拟研究旨在评估金属固定局部义齿(FPD)基托在不同载荷下使用两种不同连接体时的应力变形情况。STL 文件是为两个种植体支持的 RPD 修复体生成的。钴铬金属下部结构采用两种连接器设计。基台通过方形和圆形连接体与种植体支持的牙冠连接。这项研究是针对无骨水泥固位的种植体支持全牙冠进行设计的。使用有限元建模(FEM)来评估金属基底结构中牙冠的应力和变形,因为有限元建模可以提供与实验室和临床相关的虚拟值。泊松比和弹性模量等 Co-Cr 合金机械性能是基于三维结构添加法的参数。使用了非参数分析(曼-惠特尼 U 检验)。使用方形或圆形连接体通常会导致应力和变形发生不显著的变化,而在义齿咬合面上的三个或每个加载点下的应力和变形也不会发生显著的变化(P > 0.05)。但是,与每个加载点相比,三个加载点之间的变形有明显的不同(P ≤ 0.05)。根据这项研究的数据,无论是使用方形还是圆形连接体,在不同的负荷下,牙本质咬合面的应力和变形似乎是相同的。而在相同的连接体设计下,三个加载点上的桥体咬合面的变形比每个点上的变形都要明显。
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引用次数: 0
Complications Following Intraosseous Injections of Calcium Phosphate Bone Cement in Subchondroplasty. 软骨下置换术中骨内注射磷酸钙骨水泥后的并发症。
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023049584
Christos B Zachariadis, Helen C Leligou, Stauros K Kourkoulis, Evaggelos Magnisalis, Panayiotis J Papagelopoulos, Olga D Savvidou

An alternative approach to the major problem of osteoarthritis that has begun to pique the interest of researchers focuses on the pathology of the subchondral bone, its constant cross-talk with the articular cartilage, and its interaction with the joint. The presence of bone marrow lesions, detectable on MRI scans, has proven to be a cause of pain as well as a predictor of the progression of degenerative changes. Subchondroplasty is a relatively new surgical procedure for the treatment of these lesions, in which injectable calcium phosphate bone cement is infused into the affected area percutaneously, under fluoroscopic guidance. In its use as a synthetic scaffold, calcium phosphate bone cement exhibits considerable osteoconductivity, bioabsorbability, and low toxicity, thus showing great potential for restoring subchondral biomechanical properties through structural remodeling. Although published results appear quite promising, there are certain complications that the surgeon should be aware of. We reviewed the published data regarding complications of the procedure, highlighting possible causes according to these data, and suggesting safety measures. Avascular necrosis of the talus is the most reported concern. Postsurgical pain, infection, and continuous wound drainage due to bone substitute material extravasation to the joint or soft tissue are also mentioned, necessitating further standardization of the procedure. There are no reports of permanent postoperative disability or fatal outcomes.

研究人员开始关注软骨下骨的病理变化、软骨下骨与关节软骨之间不断发生的交叉作用以及软骨下骨与关节之间的相互作用,这也是解决骨关节炎这一主要问题的另一种方法。通过核磁共振成像扫描可发现骨髓病变的存在,这已被证明是导致疼痛的原因之一,同时也是退行性病变进展的预测因子。软骨下植入术是治疗这些病变的一种相对较新的手术方法,在透视引导下,经皮将可注射的磷酸钙骨水泥注入患处。作为一种合成支架,磷酸钙骨水泥具有相当高的骨传导性、生物吸收性和低毒性,因此在通过结构重塑恢复软骨下生物力学特性方面显示出巨大的潜力。虽然已发表的结果看起来很有希望,但外科医生应该注意某些并发症。我们回顾了已发表的有关该手术并发症的数据,根据这些数据强调了可能的原因,并提出了安全措施。报道最多的并发症是距骨血管性坏死。此外,我们还提到了术后疼痛、感染以及因骨替代材料外渗至关节或软组织而导致的伤口持续引流,因此有必要进一步规范该手术。目前还没有关于术后永久性残疾或致命后果的报道。
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引用次数: 0
Clinical Efficacy of Different Concentrations of Povidone Iodine in the Management of Peri-Implant Mucositis. 不同浓度的聚维酮碘治疗种植体周围粘膜炎的临床疗效
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023047348
S Shreenidhi, Arvina Rajasekar

Mechanical plaque control is the first line of management of peri-implant diseases. Povidone iodine is one of the broad spectrum and potent antiseptics available at various concentrations. The aim of the study was to assess and compare the efficacy of various concentrations of povidone iodine in the management of peri-implant mucositis. In the present double blinded, parallel designed, randomized clinical trial, a total of 60 patients with peri-implant mucositis (20 participants in each group [Group 1 (povidone iodine 0.1%), Group 2 (povidone iodine 2%) and Group 3 (povidone iodine 010%)] were enrolled. Scaling and root planing was done and then the peri-implant sulcus was irrigated with respective irrigant and repeated once in a week for 4 weeks. Loe and Silness Gingival Index (GI) and Mombelli Modified sulcular bleeding index (BI) were recorded at baseline and after a month and compared. Statistical analysis was done using One-way ANOVA and Tukey's HSD post hoc test. A statistically significant difference (P = 0.000) observed between the three concentrations when compared after 1 month. Also, a statistically significant difference between Group 1 and Group 3 and Group 2 and Group 3 was observed in terms of post GI (P = 0.000) and post BI (P = 0.000) but statistically no significant difference was observed between Group 1 and Group 2 in terms of post GI (P = 0.171) and post BI (P = 0.338). The 2% and 10% povidone iodine showed significant improvement in gingival index and bleeding index and hence it could be an effective adjunct to scaling and root planing in the management of peri-implant mucositis.

机械性菌斑控制是治疗种植体周围疾病的首要方法。聚维酮碘是一种广谱强效杀菌剂,有各种浓度可供选择。本研究旨在评估和比较不同浓度的聚维酮碘在治疗种植体周围粘膜炎方面的疗效。在本项双盲、平行设计、随机临床试验中,共有 60 名种植体周围粘膜炎患者参加(每组 20 人[第 1 组(聚维酮碘 0.1%)、第 2 组(聚维酮碘 2%)和第 3 组(聚维酮碘 010%)])。先进行洗牙和根面平整,然后用相应的冲洗剂冲洗种植体周围的龈沟,每周重复一次,持续 4 周。记录基线和一个月后的 Loe 和 Silness 牙龈指数(GI)和 Mombelli 改良龈沟出血指数(BI),并进行比较。统计分析采用单因素方差分析和 Tukey's HSD 后检验。1 个月后,三种浓度之间的差异有统计学意义(P = 0.000)。此外,第 1 组和第 3 组之间以及第 2 组和第 3 组之间在消化道感染后(P = 0.000)和生物感染后(P = 0.000)方面也观察到了明显的统计学差异,但第 1 组和第 2 组之间在消化道感染后(P = 0.171)和生物感染后(P = 0.338)方面没有观察到明显的统计学差异。2%和10%聚维酮碘对牙龈指数和出血指数有明显改善,因此在治疗种植体周围粘膜炎时,它可以作为洗牙和根面平整的有效辅助手段。
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引用次数: 0
Five-Year Clinical, Radiographic, and Cone-Beam Follow-Up of Socket Shield Technique in Two Cases Treated with a Split Mouth Design. 对两例采用裂口设计治疗的牙槽护罩技术进行为期五年的临床、X 射线和锥形束随访。
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023045239
Haseeb H Al Dary, Lina Droubi, Mohammed A Abuarqoub, Abeer Alhadidi, Ayman Lubbadeh

The two presented cases of socket shield technique were done following a split mouth protocol in two patients, each received an immediate implant inserted conventionally on maxillary one side and another implant inserted applying the socket shield technique on the contralateral side. The outcomes including soft and hard tissue changes were compared clinically and radiographically. The four implants were followed for 5 years, and the outcomes were successful.

所介绍的两例牙槽窝屏蔽技术是在两名患者中采用分口方案完成的,每名患者都在上颌一侧接受了传统的即刻种植体植入,并在对侧采用牙槽窝屏蔽技术植入了另一个种植体。结果包括软组织和硬组织变化的临床和影像学对比。对这四颗种植体进行了为期 5 年的随访,结果均为成功。
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引用次数: 0
Association of Age, Gender, and Site of Implant Placement: An Institution-Based Retrospective Study. 年龄、性别与植入部位的关系:一项基于机构的回顾性研究。
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023039184
Harini K Sri, Nabeel Ahmed, L Keerthi Sasanka

Tooth loss is an undesirable condition that leads to functional, esthetic and social damage, having an impact on an individual's quality of life. Dental implants are man-made tooth root replacements that are increasingly used to replace a missing tooth. It is important to gather demographic data in order to take precautions before the possible failures. Hence the objective of this study was to retrospectively determine the association between age, gender, and site of implant placement in patients reporting to a private dental institution. This study was carried out from the data obtained from the case records of 1281 patients who had undergone implant therapy. Chi-square test was applied to see associations of gender, age and implant site. The results show that a maximum number of 348 implants (27.7%) were placed in patients aged between 41-50 years. The patient pool consisted of 705 (55%) females and 576 (45%) males. A maximum of 228 implants (17.80%) were placed in region 46 and 224 implants (17.49%) in region 36. Only 2 implants (0.2%) were placed in region 41. There was a positive association between age, gender and site of implant. In those aged 20-30 years, 20.53% of implants were placed, 26.23% in 31-40 years, 27.1% in 41-50 years, 17.95% in 51-60 years and 8.11% in 61-70 years of age. In male, a maximum of 124 implants (54.4%) were placed in region 46 and only 1 implant (50%) in region 41. In females, region 36 had a maximum of 110 implants (49.1%), and the least number of implants were placed in regions 31 and 41. In this study, it can be concluded that general factors such as age and gender had a significant effect on the site of implant placement.

牙齿缺失是一种不良状况,会导致功能、美观和社会损害,影响个人的生活质量。种植牙是一种人造牙根替代物,越来越多地被用来替代缺失的牙齿。为了在可能发生故障之前采取预防措施,收集人口统计学数据非常重要。因此,本研究的目的是回顾性地确定在一家私立牙科机构就诊的患者的年龄、性别和植入部位之间的关联。这项研究是从 1281 名接受过种植治疗的患者的病例记录中获得的数据。研究采用了卡方检验来检验性别、年龄和种植部位之间的关系。结果显示,年龄在 41-50 岁之间的患者最多,共植入了 348 个种植体(占 27.7%)。患者中有 705 名女性(55%)和 576 名男性(45%)。最多的 228 个植入体(17.80%)被植入 46 区,224 个植入体(17.49%)被植入 36 区。只有 2 个植入体(0.2%)被植入 41 区。年龄、性别和植入部位之间存在正相关。在 20-30 岁的人群中,种植体植入率为 20.53%,31-40 岁为 26.23%,41-50 岁为 27.1%,51-60 岁为 17.95%,61-70 岁为 8.11%。在男性中,46 区最多植入了 124 个种植体(54.4%),41 区只有 1 个种植体(50%)。在女性中,36 区最多植入了 110 个种植体(49.1%),31 区和 41 区植入的种植体数量最少。这项研究得出的结论是,年龄和性别等一般因素对种植体植入部位有显著影响。
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引用次数: 0
The Effect of Obesity on Hemiarthroplasty and Total Hip Arthroplasty for Femoral Neck Fractures. 肥胖对股骨颈骨折半关节成形术和全髋关节成形术的影响。
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023048120
Daniel T DeGenova, Braden J Passias, Alex S Paulini, Philip M Myers, Boston Dues, Benjamin C Taylor

Obesity is a well-recognized global epidemic that can lead to longer operative times as well as a greater technical demand. Despite this, the available literature evaluating the impact of obesity on hip hemiarthroplasty (HA) and total hip arthroplasty (THA) when treating fractures about the femoral neck is scarce. Between 2015 and 2018, we retrospectively reviewed all patients that had a HA or THA performed as treatment for an isolated fracture of the femoral neck. Patients were classified as obese and nonobese depending on current body mass index (BMI) when the index procedure was performed. Preoperative and postoperative variable were obtained from the electronic medical record. A total of 157 patients underwent hip HA or THA for an isolated fracture of the femoral neck. In those patients undergoing HA, obesity was associated with an increase in operative times (P = 0.021) and was associated with a nonsignificant increase in total operating room time (P = 0.088) and duration of anesthesia (P = 0.14). In those patients undergoing THA, obesity was associated with longer operative times (P = 0.043), total operating room time (P = 0.032), and duration of anesthesia (P = 0.045). There were no significant differences in complication rates postoperatively between obese and non-obese patients undergoing either procedure. The treatment of isolated fractures of the femoral neck with HA or THA leads to an increase in operative time without an increase in postoperative complications in obese patients.

肥胖是一种公认的全球性流行病,可导致手术时间延长和技术要求提高。尽管如此,在治疗股骨颈骨折时,评估肥胖对髋关节半关节置换术(HA)和全髋关节置换术(THA)影响的现有文献却很少。2015 年至 2018 年间,我们回顾性研究了所有因股骨颈孤立性骨折而进行 HA 或 THA 治疗的患者。根据实施手术时的体重指数(BMI),患者被分为肥胖和非肥胖两类。术前和术后变量均来自电子病历。共有 157 名患者因股骨颈孤立性骨折接受了髋关节 HA 或 THA 手术。在接受髋关节置换术的患者中,肥胖与手术时间的增加有关(P = 0.021),与手术室总时间(P = 0.088)和麻醉持续时间(P = 0.14)的增加无显著关系。在接受全人工关节置换术的患者中,肥胖与手术时间(P = 0.043)、手术室总时间(P = 0.032)和麻醉时间(P = 0.045)的延长有关。接受这两种手术的肥胖患者和非肥胖患者在术后并发症发生率方面没有明显差异。用HA或THA治疗股骨颈孤立性骨折会延长肥胖患者的手术时间,但不会增加术后并发症。
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引用次数: 0
Augmentation of Rotator Cuff Repair Using Umbilical Cord Graft: A Preliminary Observational Study. 使用脐带移植增强肩袖修复术:初步观察研究
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023048123
Dimitrios V Papadopoulos, Evangelos Zafeiris, Ilias Mystidis, Vasileios S Nikolaou, George C Babis, Joseph E Imbriglia

Due to the high rate of rotator cuff re-tear there is an extensive research on augmentation of rotator cuff repairs. The purpose of this single center, prospective study was to evaluate the results of augmentation of the rotator cuff repair with an umbilical cord allograft. The graft group in which the rotator cuff repair was augmented with the graft as an on-lay patch was consisted of 14 patients, while the control group was consisted of 10 patients. The primary outcome of the study was incidence of rotator cuff retears, while secondary outcomes included functional and pain scores. At 6 mo there was a significantly higher incidence of retears in the control group (30%) compared to the graft group (0%; P = 0.028), while at 12 mo the retear rates were statistically similar for the two groups (P = 0.46). The Constant-Murley scores, the ASES scores and the VAS score were similar (P > 0.05) for the two groups at all study times. The results of the study indicated that augmentation of the cuff repair with human umbilical cord graft can result in similar patient reported outcomes compared to a cuff repair without augmentation, but with a lower re-tear rate at 6 mo.

由于肩袖再次撕裂的发生率很高,人们对肩袖修复的增量进行了广泛的研究。这项单中心前瞻性研究的目的是评估用脐带同种异体移植物增强肩袖修复术的效果。使用脐带同种异体移植物增强肩袖修复术的移植组由 14 名患者组成,对照组由 10 名患者组成。研究的主要结果是肩袖再撕裂的发生率,次要结果包括功能和疼痛评分。6 个月时,对照组的再撕裂发生率(30%)明显高于移植组(0%;P = 0.028),而 12 个月时,两组的再撕裂发生率在统计学上相似(P = 0.46)。在所有研究时间,两组的 Constant-Murley 评分、ASES 评分和 VAS 评分相似(P > 0.05)。研究结果表明,用人脐带移植物增强袖带修复术与不增强袖带修复术相比,患者报告的结果相似,但6个月后的再撕裂率更低。
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引用次数: 0
The Role of Genicular Radiofrequency Ablation in the Management of Persistent Pain after Total Knee Arthroplasty. 膝关节射频消融术在治疗全膝关节置换术后持续疼痛中的作用
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023049677
Panagiotis Karampinas, Athanasios Galanis, Michail Vavourakis, Dimitrios Tzortzis, Evangelos Sakellariou, Dimitrios Zachariou, Spiros Karampitianis, John Vlamis Spiros Pneumaticos

Persistent pain is one of the most frequent complications following total knee arthroplasty (TKA) and can be devastating for the patient's quality of life. The use of genicular nerve radiofrequency ablation (GNRFA) is prevalent regarding non-surgical treatment of knee osteoarthritis. However, it is controversial when employed for the management of residual pain after TKA. This study aims to evaluate the efficacy of GNRFA for the treatment of post-TKA chronic pain and to assess the potential benefits of its use. Twelve patients sustaining chronic pain after TKA underwent GNRFA treatment. The intervention included the superior medial genicular nerve, the superior lateral genicular nerve and the inferior medial genicular nerve. Visual analog scale (VAS) system was utilized for pain assessment at 1-week, 6-month, and 1-year follow-ups. Patients experiencing chronic knee pain derived from other or unspecified causes were excluded. Mean VAS score before the treatment was 8.3, while it ended up 2.3, 5.7, and 7.9 at the 1-week, 6-month, and 1-year follow-up, respectively. Some patients reported residual pain that they regarded more bearable than before the procedure at the 1-week evaluation, with no significant alterations in the 6-month reassessment. In 2 cases results at the 1-week follow-up were dissatisfying, however, this aided us in distinguishing the cause of the persistent pain. We were not able to conclude that GNRFA used for the treatment of chronic pain after TKA is as efficacious as in knee osteoarthritis pain. However, in some cases, it proved to be beneficial regarding discerning the etiology of the pain.

持续性疼痛是全膝关节置换术(TKA)后最常见的并发症之一,会对患者的生活质量造成严重影响。在膝关节骨性关节炎的非手术治疗中,膝神经射频消融术(GNRFA)的使用非常普遍。然而,在治疗 TKA 术后残余疼痛时,这种方法还存在争议。本研究旨在评估 GNRFA 治疗 TKA 术后慢性疼痛的疗效,并评估使用 GNRFA 的潜在益处。12 名 TKA 术后慢性疼痛患者接受了 GNRFA 治疗。干预包括上内侧膝状神经、上外侧膝状神经和下内侧膝状神经。在 1 周、6 个月和 1 年的随访中,采用视觉模拟量表(VAS)系统进行疼痛评估。由其他原因或不明原因引起的慢性膝关节疼痛患者被排除在外。治疗前的平均 VAS 评分为 8.3,而在 1 周、6 个月和 1 年的随访中分别为 2.3、5.7 和 7.9。一些患者在 1 周的评估中认为残余疼痛比治疗前更容易忍受,但在 6 个月的复查中没有明显变化。有 2 例患者在 1 周的随访中对结果不满意,但这有助于我们区分持续疼痛的原因。我们无法得出结论说,GNRFA 用于治疗 TKA 后的慢性疼痛与膝关节骨性关节炎疼痛一样有效。不过,在某些病例中,事实证明它有助于辨别疼痛的病因。
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引用次数: 0
Comparison of Roughness, Wettability, and SEM Features between Sandblasted Acid-Etched and Oxidized Titanium Dental Implants. 喷砂酸蚀钛牙科植入物与氧化钛牙科植入物的粗糙度、润湿性和扫描电镜特征比较。
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/JLongTermEffMedImplants.2023049632
Kshitiz Chhabra, Arvina Rajasekar

The surface of dental implants has undergone multiple modifications across the timeline to enhance osseointegration, thereby enhancing the success of dental implants. This study compared the surface roughness, wettability and topography of sandblasted acid-etched, and oxidized titanium dental implants. Three commercially available implants-namely, SLA, SLActive, and TiUnite-were evaluated for surface roughness in terms of Ra, Rq, and Rz; wettability in terms of contact angle (CA); and topography using scanning electron microscopy (SEM). Roughness and wettability values were compared between the three surfaces by ANOVA and pairwise comparison by Tukey's HSD post hoc testing using SPSS Software. A p value of < 0.01 was considered to be statistically significant. The TiUnite surface exhibited the highest roughness values (Ra = 1.91 ± 0.006 μm, Rq = 2.99 ± 0.005 μm, Rz = 8.37 ± 0.003 μm) followed by the SLA and SLActive surfaces. The contact angles of the SLA, SLActive, and TiUnite dental implants were 98.44 ± 0.52°, 9 ± 0.03°, and 94.39 ± 0.08°, respectively. These data demonstrated statistically significant differences between the three surfaces (p < 0.01). There were no distinct differences in SEM features between the SLA and SLActive surfaces. However, the TiUnite surface exhibited a distinctly porous morphology. Oxidized dental implants differ from sandblasted acid-etched implants in terms of roughness, wettability, and surface topography.

为了增强骨结合,从而提高种植牙的成功率,种植牙的表面历经了多次改良。本研究比较了喷砂酸蚀和氧化钛牙科种植体的表面粗糙度、润湿性和形貌。使用扫描电子显微镜 (SEM) 评估了三种市售种植体(即 SLA、SLActive 和 TiUnite)的表面粗糙度(Ra、Rq 和 Rz)、润湿性(接触角 (CA))和形貌。使用 SPSS 软件对三种表面的粗糙度和润湿性值进行方差分析和 Tukey's HSD 后检验。P 值小于 0.01 即为具有统计学意义。TiUnite 表面的粗糙度值最高(Ra = 1.91 ± 0.006 μm,Rq = 2.99 ± 0.005 μm,Rz = 8.37 ± 0.003 μm),其次是 SLA 和 SLActive 表面。SLA、SLActive 和 TiUnite 牙科种植体的接触角分别为 98.44 ± 0.52°、9 ± 0.03°和 94.39 ± 0.08°。这些数据表明三种表面之间存在显著的统计学差异(P < 0.01)。SLA 和 SLActive 表面的 SEM 特征没有明显差异。不过,TiUnite 表面呈现出明显的多孔形态。氧化牙科种植体与喷砂酸蚀种植体在粗糙度、润湿性和表面形貌方面存在差异。
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引用次数: 0
Pathophysiology of toxic effects in metallic implants 金属植入物毒性作用的病理生理学
Q3 Dentistry Pub Date : 2024-01-01 DOI: 10.1615/jlongtermeffmedimplants.2023046417
Ruchi Gupta, Priyanka Uttam, Rakesh Gupta
Implants play a very crucial role in modern era of medicine and address several needs in all the medical specialties. Both essential and nonessential metals released from implants at high concentrations can impair biological functions and result in toxicity involving multiple systems of the body. Furthermore, the toxicity information is typically based on exposure through dietary intake and/or occupational/environmental exposure but, since the in vivo implant environment and its composition is different or unknown, individual implants toxic effects needs to be elaborated. Several clinical and nonclinical assessment tools are advised by FDA to evaluate biocompatibility issues, such as risk of immunological response, tissue destruction or overgrowth, and other adverse reactions. The Center for Devices and Radiological Health (CDRH) Biocompatibility Guidelines state that biocompatibility end points caused by metallic implants includes cytotoxicity, sensitization, acute and chronic systemic toxicity, pyrogenicity, genotoxicity, carcinogenicity, implantation, hemocompatibility, reproductive abnormalities, developmental toxicity and biodegradation. Exposure to metal ions which acts as haptens can lead to both local and systemic hypersensitivity reactions which are generally believed to be a Type IV (delayed hypersensitivity) response. Currently, most assessment tools of implant associated hypersensitivity are based on skin sensitization which provides further scopes for research in understanding patient specific immune response causing systemic hypersensitivity.
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引用次数: 0
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Journal of long-term effects of medical implants
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