Enamel Matrix Derivative in the Reconstructive Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial.

IF 3.4 3区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Journal of periodontal research Pub Date : 2025-03-26 DOI:10.1111/jre.13396

Erik Regidor, Carlotta Dionigi, Martina Ghoraishi, Jon Salazar, Anna Trullenque-Eriksson, Jan Derks, Alberto Ortiz-Vigón

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引用次数: 0

Abstract

Aims: To evaluate the adjunctive effect of enamel matrix derivative (EMD) in the reconstructive surgical therapy of peri-implantitis.

Methods: Forty subjects (44 implants) affected by peri-implantitis (PPD ≥ 5 mm, positive BOP/SOP, intraosseous defect with a depth of ≥ 3 mm and width of ≤ 4 mm) were randomly allocated to one of two surgical protocols: control (access flap + bone graft + resorbable membrane) or test (access flap + bone graft + resorbable membrane + EMD). Clinical outcomes (PPD, BOP, SOP, buccal REC, and buccal KM) were assessed at baseline, 6 and 12 months after surgery. Radiographic marginal bone levels (MBL) and patient-reported outcomes (PROs) were recorded at baseline and at 12 months. Post-operative complications and Early Healing Index (EHI) scores were recorded at 2 weeks. The primary outcome was PPD change. Two composite outcomes (CO) were assessed: CO1 was defined as "implant not lost, PPD ≤ 5 mm, REC ≤ 1 mm and complete absence of BOP/SOP"; CO2 defined as CO1 but allowing for 1 site with BOP.

Results: Four patients (four implants) were lost to follow-up. At 12 months, no implants were lost, 73% of implants presented with PPD ≤ 5 mm (control: 65.2%; test: 81.0%; p = 0.316) and PPD reduction amounted to 4.0 ± 1.7 and 4.3 ± 2.4 mm in control and test groups, respectively (p = 0.105). No significant differences in terms of clinical, radiographic, composite and PROs were observed between groups. No significant differences in EHI scores were found at 2 weeks between groups.

Conclusion: This study failed to demonstrate any benefit of the adjunctive use of EMD in the reconstructive surgical therapy of peri-implantitis.

Trial registration: ISRCTN18159776 (https://doi.org/10.1186/ISRCTN18159776).

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牙釉质基质衍生物在种植体周围炎重建手术中的应用：一项随机临床试验。

目的：评价牙釉质基质衍生物（EMD）在种植周炎重建手术治疗中的辅助作用。方法：40例（44个种植体）受种植体周围炎（PPD≥5mm， BOP/SOP阳性，骨内缺损深度≥3mm，宽度≤4mm）影响的患者随机分配到两种手术方案中的一种：对照组（通路瓣+植骨+可吸收膜）或试验组（通路瓣+植骨+可吸收膜+ EMD）。临床结果（PPD、BOP、SOP、口腔REC和口腔KM）在手术后基线、6个月和12个月进行评估。在基线和12个月时记录放射学边缘骨水平（MBL）和患者报告的结果（PROs）。术后2周记录术后并发症及早期愈合指数（EHI）评分。主要结局是PPD的改变。评估两种复合结果（CO）： CO1定义为“种植体未丢失，PPD≤5 mm, REC≤1 mm， BOP/SOP完全缺失”；CO2定义为CO2，但允许有防喷器的1个站点。结果：4例患者（4颗种植体）失访。12个月时，没有种植体丢失，73%的种植体出现PPD≤5mm(对照组：65.2%；测试:81.0%;p = 0.316)，对照组和试验组PPD分别减少4.0±1.7 mm和4.3±2.4 mm （p = 0.105）。两组间临床、影像学、综合、PROs均无显著差异。2周时各组EHI评分无显著差异。结论：本研究未能证明EMD辅助应用于种植体周围炎重建手术治疗的任何益处。试验注册：ISRCTN18159776 （https://doi.org/10.1186/ISRCTN18159776）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of periodontal research 医学-牙科与口腔外科

CiteScore

6.90

自引率

5.70%

发文量

103

审稿时长

6-12 weeks

期刊介绍： The Journal of Periodontal Research is an international research periodical the purpose of which is to publish original clinical and basic investigations and review articles concerned with every aspect of periodontology and related sciences. Brief communications (1-3 journal pages) are also accepted and a special effort is made to ensure their rapid publication. Reports of scientific meetings in periodontology and related fields are also published. One volume of six issues is published annually.