釉基质衍生物治疗骨下袋缺损的两年随机临床试验：影像学分析

Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis.

作者信息

Ragghianti Zangrando Mariana Schutzer, Chambrone Daniela, Pasin Ivan Munhoz, Conde Marina Clemente, Pannuti Cláudio Mendes, de Lima Luiz Antônio Pugliesi Alves

机构信息

School of Dentistry, University of São Paulo, Av, Lineu Prestes, 2227 Cidade Universitária, 05508-000 São Paulo, SP, Brazil.

出版信息

BMC Oral Health. 2014 Dec 4;14:149. doi: 10.1186/1472-6831-14-149.

DOI:10.1186/1472-6831-14-149

PMID:25475143

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4266965/

Abstract

BACKGROUND

This split-mouth, double-blind randomized controlled trial evaluated radiographic changes in infrabony defects treated with open flap debridement (OFD) or OFD associated with enamel matrix derivative (EMD) after a 24-month follow-up. The radiographic distance from the CEJ to the bottom of the defect (BD) was considered the primary outcome. CEJ-BC and defect angle were secondary outcomes.

METHODS

Ten patients presenting 2 or more defects were selected. An individualized film holder was used to take standardized radiographs of the 43 defects, at baseline and after 24 months. Images were digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle. Statistical analysis was performed in SPSS for Windows (version 5.2). Paired samples t test was used to compare test and control groups and to evaluate changes within each group. The level of significance was set at α = 0.05%.

RESULTS

After 24 months, a significant crestal bone loss was observed for EMD (1.01 mm; p = 0.049) but not for OFD (0.14 mm; p = 0.622). However, no differences were detected between groups (p = 0.37). Reduction of the bone defect depth was significant for OFD (0.70 mm; p = 0.005) but not for EMD (0.04 mm; p = 0.86), while no differences were detected between them (p = 0.87). Both EMD (0.69°; p = 0.82) and OFD (5.71°; p = 0.24) showed an improvement in defect angle measurements but no significant differences were observed after 24 months or between the groups (p = 0.35).

CONCLUSION

Linear radiographic analysis was not able to demonstrate superiority of EMD treated infrabony defects when compared to ODF after 24 months.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02195765. Registered 17 July 2014.

摘要

背景

本双盲随机对照裂口设计试验评估了开放性龈下刮治术（OFD）或联合釉基质衍生物（EMD）的开放性龈下刮治术治疗骨下袋缺损24个月随访后的影像学变化。从牙骨质-釉质界（CEJ）到缺损底部（BD）的影像学距离被视为主要观察指标。CEJ-牙槽嵴（CEJ-BC）距离和缺损角度为次要观察指标。

方法

选取10例有2个或更多缺损的患者。使用个体化胶片夹在基线和24个月后对43个缺损拍摄标准化X线片。图像数字化后用于测量从牙骨质-釉质界（CEJ）到牙槽嵴顶（AC）、CEJ到缺损底部（BD）的距离以及骨下袋缺损角度。在Windows版SPSS（5.2版）中进行统计分析。采用配对样本t检验比较试验组和对照组，并评估每组内的变化。显著性水平设定为α = 0.05%。

结果

24个月后，观察到EMD组有显著的牙槽嵴顶骨吸收（1.01mm；p = 0.049），而OFD组无（0.14mm；p = 0.622）。然而，两组之间未检测到差异（p = 0.37）。OFD组骨缺损深度显著减小（0.70mm；p = 0.005），而EMD组无（0.04mm；p = 0.86），且两组之间未检测到差异（p = 0.87）。EMD组（0.69°；p = 0.82）和OFD组（5.71°；p = 0.24）在缺损角度测量方面均有改善，但24个月后或两组之间均未观察到显著差异（p = 0.35）。