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新型猪源去细胞真皮基质(Mucoderm)在种植体周软组织增量中的应用:一项前瞻性初步队列研究结果。

The Use of a Novel Porcine Derived Acellular Dermal Matrix (Mucoderm) in Peri-Implant Soft Tissue Augmentation: Preliminary Results of a Prospective Pilot Cohort Study.

机构信息

Department of Oral and Maxillofacial Sciences, "Sapienza" University of Rome, Italy.

出版信息

Biomed Res Int. 2018 Jul 9;2018:6406051. doi: 10.1155/2018/6406051. eCollection 2018.

Abstract

OBJECTIVE

Over the years, several techniques have been proposed for soft tissue augmentation around dental implants in order to improve keratinized mucosa width (KMW). Recently, a porcine derived acellular dermal matrix (Mucoderm®) has been proposed as autogenous graft substitute in order to avoid palatal harvesting and obtain comparable results to connective tissue grafts, in terms of aesthetics and function. The aim of this study is to present the one-year follow-up results of this matrix in peri-implant soft tissue augmentation procedures.

MATERIAL AND METHODS

Twelve patients were enrolled in this pilot prospective study: a dental implant was placed in the upper premolar area and, at implant uncovering after eight weeks, the matrix was inserted. KMW gain was considered as primary outcome variable.

RESULTS

After one month from matrix insertion, mean KMW was 7.86±3.22 mm (100%), with no statistically significant intragroup variations (>0.05). No membrane exposures or wound healing complications occurred during postoperative phase and, after one year, mean KMW was 5.67±2.12 mm (72.13%).

CONCLUSIONS

The results of the present pilot study indicate that by placing a Mucoderm membrane during implant surgery the keratinized tissue width can be augmented, and the width remains stable for the assessment period of 12 months. Further studies with greater power and longer investigation period are needed to confirm the suggestion for clinical use. Clinical trial registration number is EudraCT number 2018-000147-16.

摘要

目的

多年来,已经提出了几种用于牙种植体周围软组织增加的技术,以改善角化黏膜宽度(KMW)。最近,一种猪源性去细胞真皮基质(Mucoderm®)已被提议作为自体移植物替代物,以避免腭部采集,并获得与结缔组织移植物相当的结果,在美学和功能方面。本研究旨在介绍这种基质在种植体周围软组织增加手术中的一年随访结果。

材料和方法

本研究为前瞻性试点研究,共纳入 12 名患者:在上颌前磨牙区植入一颗牙种植体,在 8 周后种植体暴露时,插入基质。角化黏膜宽度的增加被视为主要结果变量。

结果

在基质插入后一个月,平均 KMW 为 7.86±3.22mm(100%),组内无统计学显著差异(>0.05)。在术后阶段没有发生膜暴露或伤口愈合并发症,一年后,平均 KMW 为 5.67±2.12mm(72.13%)。

结论

本初步研究结果表明,通过在种植手术期间放置 Mucoderm 膜,可以增加角化组织的宽度,并且在 12 个月的评估期内,宽度保持稳定。需要进一步进行更大样本量和更长研究时间的研究,以确认其在临床应用中的建议。临床试验注册号为 EudraCT 编号 2018-000147-16。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8553/6077540/7a4f746d5a48/BMRI2018-6406051.001.jpg

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