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牙釉质基质蛋白治疗骨内缺损。一项为期24个月的前瞻性临床试验。

Enamel matrix proteins in the treatment of intra-bony defects. A prospective 24-month clinical trial.

作者信息

Francetti Luca, Del Fabbro Massimo, Basso Matteo, Testori Tiziano, Weinstein Roberto

机构信息

Department of Odontology, Faculty of Medicine, Galeazzi Institute, University of Milan, Milan, Italy.

出版信息

J Clin Periodontol. 2004 Jan;31(1):52-9. doi: 10.1111/j.0303-6979.2004.00437.x.

DOI:10.1111/j.0303-6979.2004.00437.x
PMID:15058375
Abstract

BACKGROUND

A growing flow of recent evidence indicates enamel matrix derivative (EMD, Emdogain) as a useful tool for the regeneration of periodontal tissues. This prospective clinical study aimed to evaluate the efficacy of EMD combined with surgical treatment of periodontal intra-bony defects, as compared with surgery alone, up to 24 months of follow-up.

METHODS

Twenty-four intra-bony defects were treated in 24 patients in a single clinical centre. Each defect had intra-bony depth (IBD) > or = 4 mm and probing pocket depth (PPD) > or = 6 mm. Patients were randomly assigned to either test or control group. Plaque index (PI), gingival index (GI), PPD and periodontal attachment level (PAL) were assessed at baseline pre-surgical examination at the site to be treated. Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) were also evaluated. Twelve patients were treated by simplified papilla preservation flap technique (control group), while 12 patients were treated with the same surgical technique plus EMD after ethylenediamine tetraacetic acid root conditioning (test group). Any probing at the involved sites was avoided in the first year post-surgery. Radiographs were taken at baseline, 12 and 24 months after surgery using customized bite blocks. Intra-bony defect depth (IBD) and angle (IBA) were measured from X-rays by a computer-aided technique. At 12 and 24 months post-surgery, FMPS, FMBS, PI, GI, PPD, PAL and radiographic IBD and IBA were assessed. The difference between each follow-up and baseline, and between groups at each follow-up was evaluated for the above parameters by standard statistical methods.

RESULTS

In both groups, clinical and radiographic parameters were improved at either 12 or 24 months when compared with baseline. The test group displayed better outcomes when compared with the control group for IBD, PPD, and PAL gain at 12 months, and only for PAL and IBD gain at 24 months. No adverse event related to the use of EMD was reported.

CONCLUSIONS

The surgical procedure used in the present study, aiming for maximum preservation of the regenerative potential of periodontal tissues, showed per se excellent results. The use of EMD as an adjunct to periodontal surgery in the treatment of angular defects possibly enhances periodontal regeneration rate.

摘要

背景

最近越来越多的证据表明,釉基质衍生物(EMD,Emdogain)是牙周组织再生的一种有用工具。这项前瞻性临床研究旨在评估EMD联合牙周骨内缺损手术治疗与单纯手术相比,长达24个月随访期的疗效。

方法

在单一临床中心对24例患者的24个骨内缺损进行治疗。每个缺损的骨内深度(IBD)≥4mm,探诊袋深度(PPD)≥6mm。患者被随机分配到试验组或对照组。在待治疗部位进行术前基线检查时评估菌斑指数(PI)、牙龈指数(GI)、PPD和牙周附着水平(PAL)。还评估了全口菌斑评分(FMPS)和全口出血评分(FMBS)。12例患者采用简化乳头保留瓣技术治疗(对照组),12例患者在乙二胺四乙酸根处理后采用相同手术技术加EMD治疗(试验组)。术后第一年避免在受累部位进行任何探诊。使用定制咬块在基线、术后12个月和24个月拍摄X线片。通过计算机辅助技术从X线片中测量骨内缺损深度(IBD)和角度(IBA)。在术后12个月和24个月,评估FMPS、FMBS、PI、GI、PPD、PAL以及影像学IBD和IBA。通过标准统计方法评估上述参数在每次随访与基线之间以及各随访组间的差异。

结果

与基线相比,两组在12个月或24个月时临床和影像学参数均有改善。试验组在12个月时IBD、PPD和PAL增加方面与对照组相比显示出更好的结果,在24个月时仅在PAL和IBD增加方面优于对照组。未报告与使用EMD相关的不良事件。

结论

本研究中使用的手术程序旨在最大程度保留牙周组织的再生潜力,本身显示出优异的结果。在治疗角形缺损时,将EMD用作牙周手术的辅助手段可能会提高牙周再生率。

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