Intervention Review

Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defects

  1. Marco Esposito1,*,
  2. Maria Gabriella Grusovin2,
  3. Nikolaos Papanikolaou2,
  4. Paul Coulthard1,
  5. Helen V Worthington3

Editorial Group: Cochrane Oral Health Group

Published Online: 7 OCT 2009

Assessed as up-to-date: 26 MAY 2009

DOI: 10.1002/14651858.CD003875.pub3


How to Cite

Esposito M, Grusovin MG, Papanikolaou N, Coulthard P, Worthington HV. Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defects. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD003875. DOI: 10.1002/14651858.CD003875.pub3.

Author Information

  1. 1

    School of Dentistry, The University of Manchester, Oral and Maxillofacial Surgery, Manchester, UK

  2. 2

    School of Dentistry, The University of Manchester, Department of Oral and Maxillofacial Surgery, Manchester, UK

  3. 3

    School of Dentistry, The University of Manchester, Cochrane Oral Health Group, Manchester, UK

*Marco Esposito, Oral and Maxillofacial Surgery, School of Dentistry, The University of Manchester, Coupland 3 Building, Oxford Road, Manchester, M13 9PL, UK. espositomarco@hotmail.com. marco.esposito@manchester.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 7 OCT 2009

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Periodontitis is a chronic infective disease of the gums caused by bacteria present in dental plaque. This condition induces the breakdown of the tooth supporting apparatus until teeth are lost. Surgery may be indicated to arrest disease progression and regenerate lost tissues. Several surgical techniques have been developed to regenerate periodontal tissues including guided tissue regeneration (GTR), bone grafting (BG) and the use of enamel matrix derivative (EMD). EMD is an extract of enamel matrix and contains amelogenins of various molecular weights. Amelogenins are involved in the formation of enamel and periodontal attachment formation during tooth development.

Objectives

To test whether EMD is effective, and to compare EMD versus GTR, and various BG procedures for the treatment of intrabony defects.

Search methods

We searched the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE and EMBASE. Several journals were handsearched. No language restrictions were applied. Authors of randomised controlled trials (RCTs) identified, personal contacts and the manufacturer were contacted to identify unpublished trials. Most recent search: February 2009.

Selection criteria

RCTs on patients affected by periodontitis having intrabony defects of at least 3 mm treated with EMD compared with open flap debridement, GTR and various BG procedures with at least 1 year follow up. The outcome measures considered were: tooth loss, changes in probing attachment levels (PAL), pocket depths (PPD), gingival recessions (REC), bone levels from the bottom of the defects on intraoral radiographs, aesthetics and adverse events. The following time-points were to be evaluated: 1, 5 and 10 years.

Data collection and analysis

Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two authors. Results were expressed as random-effects models using mean differences for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI). It was decided not to investigate heterogeneity, but a sensitivity analysis for the risk of bias of the trials was performed.

Main results

Thirteen trials were included out of 35 potentially eligible trials. No included trial presented data after 5 years of follow up, therefore all data refer to the 1-year time point. A meta-analysis including nine trials showed that EMD treated sites displayed statistically significant PAL improvements (mean difference 1.1 mm, 95% CI 0.61 to 1.55) and PPD reduction (0.9 mm, 95% CI 0.44 to 1.31) when compared to placebo or control treated sites, though a high degree of heterogeneity was found. Significantly more sites had < 2 mm PAL gain in the control group, with RR 0.53 (95% CI 0.34 to 0.82). Approximately nine patients needed to be treated (NNT) to have one patient gaining 2 mm or more PAL over the control group, based on a prevalence in the control group of 25%. No differences in tooth loss or aesthetic appearance as judged by the patients were observed. When evaluating only trials at a low risk of bias in a sensitivity analysis (four trials), the effect size for PAL was 0.62 mm (95% CI 0.28 to 0.96), which was less than 1.1 mm for the overall result. Comparing EMD with GTR (five trials), GTR showed statistically significant more postoperative complications (three trials, RR 0.12, 95% CI 0.02 to 0.85) and more REC (0.4 mm 95% CI 0.15 to 0.66). The only trial comparing EMD with a bioactive ceramic filler found statistically significant more REC (-1.60 mm, 95% CI -2.74 to -0.46) at the EMG treated sites.

Authors' conclusions

One year after its application, EMD significantly improved PAL levels (1.1 mm) and PPD reduction (0.9 mm) when compared to a placebo or control, however, the high degree of heterogeneity observed among trials suggests that results have to be interpreted with great caution. In addition, a sensitivity analysis indicated that the overall treatment effect might be overestimated. The actual clinical advantages of using EMD are unknown. With the exception of significantly more postoperative complications in the GTR group, there was no evidence of clinically important differences between GTR and EMD. Bone substitutes may be associated with less REC than EMD.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Enamel matrix derivative (Emdogain®) for periodontal tissue regeneration in intrabony defects

Emdogain might have some advantages over other methods of regenerating the tissue supporting teeth lost by gum disease, such as less postoperative complications, but has not been shown to save more compromised teeth or that patients noticed any aesthetic improvement 1 year after its application.
Bacteria in plaque can cause gum disease (periodontitis) that breaks down tissue supporting teeth. Surgical cleaning tries to stop the disease to save loose teeth. Bone grafting, guided tissue regeneration and enamel matrix derivatives (such as Emdogain) aim to regenerate support tissues. Emdogain contains proteins (derived from developing pig teeth) believed to regenerate tooth attachment. The review found that adjunctive application of Emdogain regenerates about 1 mm more tissue than surgical cleaning alone, although it is unclear to which extent such improvement is noticeable since patients did not find any difference in the aesthetic results. Emdogain showed similar clinical results to guided tissue regeneration, but is simpler to use and determines less complications. Bone substitutes may induce less gum retraction than Emdogain. No serious adverse reactions to Emdogain were reported in trials.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

牙釉基質衍生物(EmdogainR)用於骨內缺損之牙周組織再生的應用

牙周病是一種因牙菌斑中的細菌造成之牙齦慢性感染性疾病。這種狀況引發牙齒支持結構破壞,直到喪失牙齒。手術可能是停止疾病進展和組織再生之必要方法。已發展的牙周組織再生手術包括引導組織再生(GTR),骨移植術(BG),及使用牙釉基質衍生物(EMD)等。EMD是一種牙釉基質提取物,含有不同分子量的齒釉蛋白(amelogenins)。而齒釉蛋白在牙齒發育過程中則參與牙釉質和牙周附連的形成。

目標

測試EMD是否有效,並與GTR以及各種BG手術比較治療骨內缺損的有效性。

搜尋策略

搜尋考科藍口腔健康團隊之試驗登錄,CENTRAL,MEDLINE,以及EMBASE。有些期刊則是以人工搜尋方式進行。對於語言不加以限制。對於隨機對照試驗(RCT)之作者,針對個人和製造商進行聯繫,以確定未發表的試驗。最近期的搜尋為2009年2月。

選擇標準

牙周病合併有至少3mm骨內缺損的患者以EMD治療,與翻瓣清創,GTR,及各種BG手術之隨機對照試驗比較,追蹤至少1年。針對以下幾項作結果評估:牙齒脫落,探測附連高度(PAL)的變化水平,囊袋深度(PPD),牙齦萎縮(REC),口內 X光片上缺陷底部至骨水平之距離,美觀,和不良反應等。並針對以下之時間點作評估:1,5,10年。

資料收集與分析

由兩位作者分別及重複篩選合適之研究,評估試驗方法之品質,以及選取數據。結果以隨機效應模型表式示,平均差異用於連續結果,風險比(RR)用於二分類結果,並採以95%信賴區間(CI)。我們決定不針對異質性作調查,但對試驗差異的風險進行靈敏度分析。

主要結論

我們從35個潛在的合格試驗中選錄13個試驗。沒有任何一個選錄的試驗在5年的追蹤之後提供數據,因此所有數據皆是指1年的時間點。一個包含9個試驗的統合分析顯示經EMD治療後的患部和安慰劑或對照組治療處相比,在PAL方面有統計上的顯著改善(平均差異1.1mm,95%CI為 0.61至1.55),以及顯著的PPD減少(0.9mm,95%CI為 0.44至1.31),雖然同時顯示高度之異質性。值得注意的更多對照組的患部有<2mm之PAL增加,其RR為 0.53(95%CI為 0.34至0.82)。基於對照組的患病率在25%,若要有1名患者獲得 2 mm以上的PAL,則需要有大約9名患者接受治療(NNT)。由患者的角度進行判斷,並無觀察到牙齒脫落或美觀方面的差異。當評估只有在敏感性分析中有低風險的偏差的試驗時(四項試驗),其PAL的效應值為 0.62mm(95%CI為 0.28至0.96),和整體結果相比少了 1.1mm。EMD與GTR相比(5項試驗),GTR在統計學上併發症顯著較多(三項試驗,RR為0.12,95%CI為 0.02~0.85),REC也顯著增加(0.4mm 95%CI為0.15 – 0.66)。唯一有比較EMD與生物活性陶瓷填料的試驗,在經EMD治療過之患處發現統計學上顯著的REC(−1.60mm,95%CI為 −2.74至 −0.46)。

作者結論

和安慰劑或對照組相比,使用EMD治療一年後,PAL高度顯著增加(1.1mm),PPD也顯著減少(0.9mm);然而,在各個試驗中觀察到的高度異質性顯示,要以十分謹慎的態度來解讀結果。此外,敏感性分析顯示,整體治療的效果可能被高估。實際利用EMD的臨床優勢是未知的。除了GTR有顯著較高的術後併發症之外, GTR和EMD沒有臨床重要差異的證據。骨替代物可能比EMD產生較少的REC。

翻譯人

本摘要由臺灣大學附設醫院陳思齊翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

牙釉基質衍生物(EmdogainR)用於骨內缺損之牙周組織再生的應用 在因牙周病變而喪失牙齒支持組織之疾病當中,Emdogain與其他方法相比,對於組織再生有一定的優勢,例如術後併發症較少,但並無被證實在治療一年後可因此拯救更多岌岌可危的牙齒,或者患者注意到有任何美觀方面的改善。牙菌斑中的細菌會導致牙齦疾病(牙周炎),進而壞組織支持的牙齒。以手術方法清潔可試圖阻止這種疾病以及保存鬆動的牙齒。骨移植術,引導組織再生手術,和牙釉基質衍生物(如Emdogain)目標在於使支持組織再生。 Emdogain含有被認為可使牙齒附連再生的蛋白質(衍生自發育中的豬牙)。本篇文獻回顧發現,輔助施以Emdogain比單獨使用手術方式清潔可再生多出約 1mm的組織,不過我們不清楚到什麼程度的改善才會比較明顯,因為患者在美觀方面的結果並沒有感到有任何不同處。Emdogain和引導組織再生手術有相似的臨床結果,但較易於使用,並有較少的併發症。骨替代物可能比Emdogain造成較少的牙齦退縮量。在試驗中並無發現Emdogain的嚴重不良反應。