Yamada Junichi, Kori Hidehiro, Tsukiyama Yoshihiro, Matsushita Yasuyuki, Kamo Makoto, Koyano Kiyoshi
Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):184-93. doi: 10.11607/jomi.3679.
The purpose of this study was to evaluate prospectively the clinical effectiveness of immediate loading of implants with complete-arch fixed prostheses in edentulous maxillae after the implants were placed with flapless guided surgery.
Patients with edentulous maxillae who visited a single dental clinic during the recruitment period (April 2011 to May 2012) were selected by consecutive sampling and predetermined selection criteria. Four to six implants were placed in each patient with flapless guided surgery. The outcome measures were insertion torque, surgical time, postoperative pain (100-mm visual analog scale), marginal bone level change, implant survival, and oral health-related quality of life. Patients were followed for up to 1 year.
Fifty patients received 290 implants. All implants were immediately loaded 2 hours after placement with prefabricated fixed provisional prostheses. Two patients dropped out of the study. Hence, analyses were conducted for 278 implants in 48 patients (26 men, 22 women; mean age 56.0 ± 8.3 years; age range, 34 to 74 years). The average insertion torque was 57.7 ± 16.6 Ncm, the average surgical time was 22.9 ± 4.7 minutes, and the average score for postoperative pain was 14.7 ± 9.3. One year after immediate loading, the implant survival rate was 98.6%. Four implants showed mobility early after implant placement and were lost. Mean marginal bone level changes were -0.32 ± 0.43 mm. Scores on the Oral Health Impact Profile-54 (Japanese version) improved significantly after prosthetic treatment.
The results of this study indicate that this treatment method for edentulous maxillae is predictable, with a high implant survival rate and a clinically reasonable improvement in oral health-related quality of life.
本研究的目的是前瞻性评估在无牙上颌骨中通过不翻瓣引导手术植入种植体后，即刻用全牙弓固定修复体加载种植体的临床效果。
在招募期间（2011年4月至2012年5月）到单一牙科诊所就诊的无牙上颌骨患者，通过连续抽样和预定的选择标准进行选取。每位患者通过不翻瓣引导手术植入4至6颗种植体。观察指标包括植入扭矩、手术时间、术后疼痛（100毫米视觉模拟量表）、边缘骨水平变化、种植体存留率以及口腔健康相关生活质量。对患者进行长达1年的随访。
50例患者共植入290颗种植体。所有种植体在植入后2小时即刻用预制的固定临时修复体进行加载。2例患者退出研究。因此，对48例患者（26例男性，22例女性；平均年龄56.0±8.3岁；年龄范围34至74岁）的278颗种植体进行了分析。平均植入扭矩为57.7±16.6牛厘米，平均手术时间为22.9±4.7分钟，术后疼痛平均评分为14.7±9.3。即刻加载后1年，种植体存留率为98.6%。4颗种植体在植入后早期出现松动并脱落。边缘骨水平平均变化为-0.32±0.43毫米。修复治疗后，口腔健康影响程度量表-54（日语版）评分有显著改善。
本研究结果表明，这种针对无牙上颌骨的治疗方法具有可预测性，种植体存留率高，且在口腔健康相关生活质量方面有临床上合理的改善。
