Use of autogenous bone versus deproteinised bovine bone matrix in one-stage lateral sinus floor elevation in severely atrophied maxillae: A 7-year randomised controlled trial.

Mauro Merli, Marco Moscatelli, Giorgia Mariotti, Umberto Pagliaro, Marco Merli, Michele Nieri
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Abstract

Purpose: To compare 100% deproteinised bovine bone matrix grafts (DBBM, test group) and 100% autogenous bone grafts (AB, control group) for lateral maxillary sinus floor elevation in a blinded, parallel-group, randomised clinical trial.

Materials and methods: Patients with 1 to 3 mm of residual bone height were randomised for sinus floor elevation with DBBM or AB grafts and simultaneous implant placement. The outcome variables were implant failure, complications, subjective satisfaction and radiographic peri-implant bone level 7 years after loading.

Results: A total of 20 patients (27 implants) were randomised to the test group and 20 (32 implants) to the control group. Ten patients from the test group and seven from the control group dropped out. Two implant failures occurred in the test group, whereas none were observed in the control group (P = 0.178). One complication occurred in the test group and two were recorded in the control group (P = 1.000). The radiographic peri-implant crestal bone level was 2.5 ± 1.3 mm in the test group and 0.9 ± 0.9 mm in the control group. The difference was 1.6 mm, favouring the control group (95% confidence interval 0.7-2.6; P = 0.002). The difference in vertical bone height was -0.4 mm, favouring the control group (95% confidence interval -1.9-1.1; P = 0.590). The difference in satisfaction measured using a visual analogue scale 7 years after loading was 0.0 mm (95% confidence interval -1.0-0.0; P = 0.639).

Conclusions: Differences between treatments were found for crestal bone level, favouring the control group. No differences were observed for the other variables evaluated.

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使用自体骨与脱蛋白牛骨基质治疗严重萎缩上颌的一期侧窦底抬高:一项为期7年的随机对照试验。
目的:在一项盲法、平行组、随机临床试验中,比较100%去蛋白牛骨基质移植物(DBBM,试验组)和100%自体骨移植物(AB,对照组)治疗上颌窦外侧底抬高的效果。材料和方法:残骨高度为1 ~ 3mm的患者随机分为窦底抬高组和DBBM或AB移植物组。结果变量包括种植体失败、并发症、主观满意度和植入后7年种植体周围骨水平。结果:试验组共20例(27颗种植体),对照组共20例(32颗种植体)。试验组10名患者退出,对照组7名患者退出。实验组出现2例种植失败,对照组无一例失败(P = 0.178)。实验组出现1例并发症,对照组出现2例并发症(P = 1.000)。试验组种植体周冠骨水平为2.5±1.3 mm,对照组为0.9±0.9 mm。差异为1.6 mm,有利于对照组(95%置信区间0.7-2.6;P = 0.002)。垂直骨高度差异为-0.4 mm,优于对照组(95%可信区间-1.9-1.1;P = 0.590)。加载后7年使用视觉模拟量表测量的满意度差异为0.0 mm(95%置信区间-1.0-0.0;P = 0.639)。结论:两种治疗方法在冠骨水平上存在差异,对照组优于对照组。对其他变量的评估没有观察到差异。
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