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下颌第一磨牙即刻非咬合负重与延迟负重:一项随机对照试验的五年结果

Immediate non-occlusal versus delayed loading of mandibular first molars. Five-year results from a randomised controlled trial.

作者信息

Meloni Silvio Mario, Baldoni Edoardo, Duvina Marco, Pisano Milena, De Riu Giacomo, Tallarico Marco

出版信息

Eur J Oral Implantol. 2018;11(4):409-418.

Abstract

PURPOSE

To compare outcomes of immediate non-occlusal loading with delayed implant loading in the bilateral replacement of mandibular first molars.

MATERIALS AND METHODS

This study was designed as a split-mouth, randomised controlled trial. Twenty patients with bilaterally missing mandibular first molars randomly received immediately or conventionally loaded single implants. One molar was restored with a non-occlusal temporary crown within 24 hours after implant placement (immediate loading group, IL) while the contralateral molar was restored with a definitive crown 4 to 5 months later (delayed loading group, DL). A total of 40 implants were installed. All implants were inserted in healed bone with an insertion torque between 35 and 45 Ncm. Outcome measures were implant failure, complications, radiographic marginal bone level changes, probing pocket depths (PPDs) and bleeding on probing (BOP). Clinical data were collected at implant placement, and after 6, 12 and 60 months.

RESULTS

No patients dropped out and no implant failed. Only minor prosthetic complications were observed (two provisional acrylic crown fractures in the IL group and four ceramic chipping in the DL group). Two patients had bilateral peri-implant mucosal inflammation with BOP after 6 months. The differences between groups were not statistically significant (OR = 0.500; 95% CI: 0.045 to 3.489; P = 0.6831). At the 1-year follow-up examination, the mean marginal bone level was 0.83 ± 0.16 mm (95% CI: 0.75 to 0.91) in the IL group and 0.86 ± 0.16 mm (95% CI: 0.78 to 0.94) in the DL group, with no statistically significant differences between groups (difference = 0.03 ± 0.15 mm; 95% CI: -0.07 to 0.07; P = 0.53). After 5 years, mean marginal bone level was 1.06 ± 0.38 mm (95% CI: 0.97 to 1.15) in the IL group and 1.07 ± 0.32 mm (95% CI: 0.95 to 1.16) in the DL group, with no statistically significant differences between groups (difference = 0.01 ± 0.22 mm; 95% CI: -0.10 to 0.10; P = 0.96). The mean marginal bone loss after 5 years was 0.62 ± 0.45 mm in the IL group and 0.69 ± 0.33 mm in the DL group (difference = 0.07 ± 0.32 mm; 95% CI: -0.10 to 0.18; P = 0.567). At the 5-year follow-up the mean PPD and BOP values were 2.82 ± 0.65 mm and 1.17 ± 0.92 in the IL group, and 2.85 ± 0.53 mm and 1.17 ± 0.86 in the DL group, respectively. No significant differences were found (difference = 0.03 ± 0.15 mm; 95% CI: -0.15 to 0.21; P = 0.990; and 0.01 ± 0.07; 95% CI: -0.06 to 0.08; P = 1.000, respectively).

CONCLUSIONS

Within the limitations of this study, the present data seem to confirm the hypothesis that the clinical outcome of immediate versus delayed loading of implants in mandibular fist molar sites is comparable.

摘要

目的

比较下颌第一磨牙双侧种植时即刻非咬合负重与延期种植负重的效果。

材料与方法

本研究设计为一项双侧对照、随机对照试验。20例双侧下颌第一磨牙缺失患者随机接受即刻或传统负重的单颗种植体。一侧磨牙在种植体植入后24小时内用非咬合临时冠修复(即刻负重组,IL),而对侧磨牙在4至5个月后用永久冠修复(延期负重组,DL)。共植入40颗种植体。所有种植体均植入愈合骨中,植入扭矩在35至45 Ncm之间。观察指标包括种植体失败、并发症、影像学边缘骨水平变化、探诊深度(PPD)和探诊出血(BOP)。在种植体植入时以及6、12和60个月后收集临床数据。

结果

无患者退出研究,也没有种植体失败。仅观察到轻微的修复并发症(IL组有2例临时丙烯酸冠骨折,DL组有4例陶瓷崩裂)。6个月后,2例患者双侧种植体周围黏膜出现炎症并伴有探诊出血。两组之间的差异无统计学意义(OR = 0.500;95% CI:0.045至3.489;P = 0.6831)。在1年随访检查时,IL组平均边缘骨水平为0.83±0.16 mm(95% CI:0.75至0.91),DL组为0.86±0.16 mm(95% CI:0.78至0.94)两组之间无统计学显著差异(差值 = 0.03±0.15 mm;95% CI:-0.07至0.07;P = 0.53)。5年后,IL组平均边缘骨水平为1.06±0.38 mm(95% CI:0.97至1.15),DL组为1.07±0.32 mm(95% CI:0.95至1.16),两组之间无统计学显著差异(差值 = 0.01±0.22 mm;95% CI:-0.10至0.10;P = 0.96)。5年后IL组平均边缘骨吸收为0.62±0.45 mm,DL组为0.69±0.33 mm(差值 = 0.07±0.32 mm;95% CI:-0.10至0.18;P = 0.567)。在5年随访时,IL组平均PPD和BOP值分别为2.82±0.65 mm和1.17±0.92,DL组分别为2.85±0.53 mm和1.17±0.86。未发现显著差异(差值 = 0.03±0.15 mm;95% CI:-0.15至0.21;P = 0.990;以及0.01±0.07;95% CI:-0.06至0.08;P = 1.000)。

结论

在本研究的局限性范围内,目前的数据似乎证实了以下假设:在下颌第一磨牙部位,种植体即刻负重与延期负重的临床效果相当。

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