Lindeboom Jerome A, Frenken Joost W, Dubois Leander, Frank Michael, Abbink Ingmar, Kroon Frans H
Department of Oral and Maxillofacial Surgery, Academic Medical Center and Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam, Amsterdam, The Netherlands.
J Oral Maxillofac Surg. 2006 Jun;64(6):936-42. doi: 10.1016/j.joms.2006.02.015.
The aim of this prospective randomized study was to evaluate the clinical outcome of immediately loaded solid plasma sprayed (TPS) BioComp (BioComp Industries BV, Vught, The Netherlands) implants versus immediate provisionalized but non-loaded BioComp implants in the anterior and premolar region of the maxilla.
Forty-eight patients (31 females and 17 males) with a mean age of 42.3+/-13.1 years (range 19 to 78 years) were included in the study. Fifty threaded TPS implants were placed and provisionalized within 24 hours after surgery. The patients were randomly assigned to 2 groups. In the immediate loaded (IL) group (n=24) the occlusion of the provisional was designed with normal contacts in centric relation and at lateral excursions, while in the non-immediate loaded (IP) group (n=24) the provisional restoration was adjusted to clear all occlusal contacts or contacts at lateral excursions. Patients were instructed to eat a soft diet and to avoid placing food in the area of the provisional crown during the first 6 weeks. Regular clinical and radiographic controls were performed and the survival rate and implant stability quotient (ISQ) values were evaluated at delivery of the definitive restoration at 6 months. At 1 year, radiographic coronal bone defects and gingival esthetics between the 2 groups were assessed.
Of the IL group, 2 fixtures were lost, while 3 implants were lost in the IP group. The failing implants showed increasing mobility at 2 to 3 weeks after insertion, and were removed. The remaining 45 implants were stable at every subsequent follow-up examination, and 6 months after implant placement, ISQ values were measured. The mean ISQ value in the IL group was 63.7+/-5.8 versus 63.2+/-4.3 for the IP group (P=.78). The mean mesial marginal bone loss after 12 months in the IL group was 0.27+/-0.2 mm versus 0.28+/-0.22 mm in the IP group (P=.9). The mean distal marginal bone loss after 12 months in the IL group was 0.19+/-0.15 mm versus 0.2+/-0.11 mm in the IP group (P=.87). All implants of the IL group had an ideal gingival buccal margin, versus 91% of the IP group. Full regeneration of the mesial interdental papilla was observed in 70% of the IL group versus 91% of the IP group, while full regeneration of the distal papilla was observed in 91% of both the IL and IP implants.
No significant differences in ISQ mean values in radiographic bone loss and gingival esthetics were found between immediate non-loaded provisionalization and immediately loaded BioComp implants in the maxilla.
本前瞻性随机研究旨在评估在上颌前部和前磨牙区即刻加载的固体等离子喷涂（TPS）BioComp种植体（荷兰武赫特BioComp工业公司）与即刻临时修复但未加载的BioComp种植体的临床效果。
本研究纳入48例患者（31例女性和17例男性），平均年龄42.3±13.1岁（范围19至78岁）。植入50枚带螺纹的TPS种植体，并在术后24小时内进行临时修复。患者被随机分为2组。在即刻加载（IL）组（n = 24）中，临时修复体的咬合设计为在正中关系和侧方运动时具有正常接触，而在非即刻加载（IP）组（n = 24）中，临时修复体被调整为消除所有咬合接触或侧方运动时的接触。患者被指示在最初6周内食用软食，并避免在临时冠区域放置食物。进行定期的临床和影像学检查，并在6个月最终修复体交付时评估生存率和种植体稳定性商（ISQ）值。在1年时，评估两组之间的影像学冠方骨缺损和牙龈美学情况。
IL组有2枚种植体丢失，而IP组有3枚种植体丢失。失败的种植体在植入后2至3周时出现活动度增加，并被取出。其余45枚种植体在随后的每次随访检查中均稳定，并在种植体植入6个月时测量ISQ值。IL组的平均ISQ值为63.7±5.8，而IP组为63.2±4.3（P = 0.78）。IL组在12个月后的平均近中边缘骨吸收为0.27±0.2mm，而IP组为0.28±0.22mm（P = 0.9）。IL组在12个月后的平均远中边缘骨吸收为0.19±
