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有或无软组织增量的拔牙后种植体的临床及美学效果:一项为期2年的随机临床试验

Clinical and Aesthetic Outcome with Post-Extractive Implants with or without Soft Tissue Augmentation: A 2-Year Randomized Clinical Trial.

作者信息

Migliorati Marco, Amorfini Leonardo, Signori Alessio, Biavati Armando Silvestrini, Benedicenti Stefano

机构信息

Orthodontics Department, Genoa University, Genova, Italy.

Oral Surgery Departments, Gallarate, Milan, Italy.

出版信息

Clin Implant Dent Relat Res. 2015 Oct;17(5):983-95. doi: 10.1111/cid.12194. Epub 2013 Dec 27.

Abstract

BACKGROUND

The aesthetic outcome of an implant-supported restoration is first of all dependent on the soft tissue volume. Because the labial bone plate resorbs in every direction after tooth extraction, even when an implant is placed immediately, most patients end up with compromised aesthetics.

MATERIALS AND METHODS

In this parallel-designed, randomized clinical trial, participants were randomly assigned to the test group (immediate load post-extractive implant treated with subepithelial connective tissue graft placed using the tunnel technique in the labial area) and control group (immediate load post-extractive implant treated without raising a flap) with an allocation ratio of 1:1. Both groups received deproteinized bovine bone mineral. Patients were observed at baseline, crown insertion, 1-year follow-up, and 2-year follow-up. Clinical, radiological and aesthetic parameters were recorded to assess primary treatment outcomes. A random permuted block system was blindly generated ensuring uniformity of the patient allocation during the trial by randomly distributing three participants to the test and three participants to the control group every six treated patients.

RESULTS

At the 2-year examination, all 47 implants were successfully integrated, demonstrating stability and healthy peri-implant soft tissues as documented by standard clinical parameters. The results showed a soft tissue remodeling of -10% in thickness and -18% in highness in the non-grafted group, whereas in the grafted group there was a gain of 35% in thickness and a slight reduction of -11% in highness. Test group reported an increase of aesthetic result (mean pink aesthetic score [PES] 8) compared with control group (mean PES 6.65).

CONCLUSIONS

This prospective study demonstrates the effectiveness of placing a soft tissue graft at the time of immediate implant placement in the aesthetic zone. At the 2-year follow-up, test group revealed a better aesthetic outcomes and stable facial soft tissues compared with control group.

摘要

背景

种植体支持修复体的美学效果首先取决于软组织体积。由于拔牙后唇侧骨板会向各个方向吸收,即使立即植入种植体,大多数患者最终的美学效果仍会受损。

材料与方法

在这项平行设计的随机临床试验中,参与者被随机分配到试验组(拔牙后即刻种植并即刻负重,采用隧道技术在唇侧区域放置上皮下结缔组织移植片)和对照组(拔牙后即刻种植并即刻负重,不翻瓣),分配比例为1:1。两组均接受脱蛋白牛骨矿物质。在基线、牙冠植入时、1年随访和2年随访时对患者进行观察。记录临床、放射学和美学参数以评估主要治疗结果。通过随机排列区组系统盲目生成,确保在试验期间每治疗6名患者时,随机将3名参与者分配到试验组,3名参与者分配到对照组,从而保证患者分配的均匀性。

结果

在2年检查时,所有47枚种植体均成功整合,标准临床参数记录显示种植体稳定且周围软组织健康。结果显示,未移植组软组织厚度重塑减少10%,高度减少18%,而移植组厚度增加35%,高度略有减少11%。试验组报告美学效果有所提高(平均粉色美学评分[PES]为8),而对照组为(平均PES 6.65)。

结论

这项前瞻性研究证明了在美学区即刻种植时放置软组织移植片的有效性。在2年随访时,试验组与对照组相比,美学效果更好,面部软组织更稳定。

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